Clinical Trial Results:
Neuroplasticity induced by general anaesthesia
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Summary
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EudraCT number |
2018-001252-35 |
Trial protocol |
DK |
Global end of trial date |
13 Aug 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Mar 2025
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First version publication date |
01 Mar 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DANA-2018-1.
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04125121 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Rigshospitalet
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Sponsor organisation address |
Valdemar Hansens Vej 15, Glostrup, Denmark, DK-2600
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Public contact |
Glostrup, Rigshospitalet, signe.sloth.madsen@regionh.dk
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Scientific contact |
Glostrup, Rigshospitalet, +45 38633156, signe.sloth.madsen@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Aug 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Aug 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Aug 2021
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To explore and compare possible the de novo neuroplastic changes (visualised by magnetic resonnance imaging (MRI)) induced by anaesthesia with a volatile agent (sevoflurane) and total intravenous anaesthesia (propofol) respectively.
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Protection of trial subjects |
Any condition (or history thereof) that could cause or be suspected to cause contraindications for general anaesthesia or magnetic resonance imaging led to non-inclusion or exclusion from the trial. Participants could withdraw from participation at any time without having to state a reason for cessation of participation. The participants could contact the principal investigator directly by phone call, text message or e-mail, and were encouraged to do so in case of any question or concern at any time throughout their participation. Inclusion and exclusion criteria were revisited with the participants before each session in the study, and informed consent was reconfirmed before intervention (general anaesthesia). The comfort and safety of the participants were first priority in all aspects of this trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Sep 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 23
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Worldwide total number of subjects |
23
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EEA total number of subjects |
23
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
23
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited in Denmark via online advertising and in magazines for medical students in Copenhagen. Information and screening of applicants for eligibility, physical examinations, and obtainment of informed consent as was carried out by a physician at Rigshospitalet Glostrup, Denmark. | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
For detailed inclusion and exclusion criteria, please refer to www.clinicaltrials.gov, trial ID NCT04125121, and protocol article published in Trials 2020: DOI 10.1186/s13063-020-04468-y. Recruitment, screening and inclusion was carried out continuously throughout the trial period. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||||||||
Roles blinded |
Subject | ||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Sevoflurane | ||||||||||||||||||||||||
Arm description |
1. Confirmation of eligibility for participation. 2. Baseline magnetic resonance imaging. 3. Intervention: Two hours of general anaesthesia with sevoflurane. 4. Magnetic resonance imaging four hours after general anaesthesia with sevoflurane. 5. Magnetic resonance imaging one day after general anaesthesia with sevoflurane. 6. Magnetic resonance imaging eight days after general anaesthesia with sevoflurane. Questionnaires, cognitive testing and blood sampling was carried out corresponding to each MRI scan. | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Sevoflurane
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation vapour, Medicinal gas, liquefied
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two hours of general anaesthesia with sevoflurane, minimum alveolar concentration (MAC) 1.5 or lower.
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Arm title
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Propofol | ||||||||||||||||||||||||
Arm description |
1. Confirmation of eligibility for participation. 2. Baseline magnetic resonance imaging. 3. Intervention: Two hours of general anaesthesia with propofol. 4. Magnetic resonance imaging four hours after general anaesthesia with propofol. 5. Magnetic resonance imaging one day after general anaesthesia with propofol. 6. Magnetic resonance imaging eight days after general anaesthesia with propofol. Questionnaires, cognitive testing and blood sampling was carried out corresponding to each MRI scan. | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Propofol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Emulsion for infusion, Emulsion for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Two hours of general anaesthesia with propofol, infused with target controlled infusion using Schnider’s pharmacokinetic model for propofol.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial period
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Reporting group description |
23 subjects were included and proceeded to randomisation. After randomisation, two subjects were excluded due to protocol violation, and one subject withdrew from further participation after completing one arm (propofol). Thus, results from 21 subjects were included in further analysis from the propofol arm, while data from 20 subjects are included in the analysis from the sevoflurane arm, and two subjects appear at baseline while their data could not be used for further analysis. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Sevoflurane
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Reporting group description |
1. Confirmation of eligibility for participation. 2. Baseline magnetic resonance imaging. 3. Intervention: Two hours of general anaesthesia with sevoflurane. 4. Magnetic resonance imaging four hours after general anaesthesia with sevoflurane. 5. Magnetic resonance imaging one day after general anaesthesia with sevoflurane. 6. Magnetic resonance imaging eight days after general anaesthesia with sevoflurane. Questionnaires, cognitive testing and blood sampling was carried out corresponding to each MRI scan. | ||
Reporting group title |
Propofol
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Reporting group description |
1. Confirmation of eligibility for participation. 2. Baseline magnetic resonance imaging. 3. Intervention: Two hours of general anaesthesia with propofol. 4. Magnetic resonance imaging four hours after general anaesthesia with propofol. 5. Magnetic resonance imaging one day after general anaesthesia with propofol. 6. Magnetic resonance imaging eight days after general anaesthesia with propofol. Questionnaires, cognitive testing and blood sampling was carried out corresponding to each MRI scan. | ||
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End point title |
Sevoflurane, Whole brain volume, Baseline [1] [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| Notes [3] - One participant was excluded after allocation to sevoflurane, 20 participants completed the arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Whole brain volume, +4 hours [4] [5] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+4 hours after emergence from general anaesthesia with sevoflurane
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| Notes [6] - One participant was excluded after allocation to sevoflurane, 20 participants completed the arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Whole brain volume, +1 day [7] [8] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+1 day after emergence from general anaesthesia with sevoflurane
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| Notes [9] - One participant was excluded after allocation to sevoflurane, 20 participants completed the arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Whole brain volume, +8 days [10] [11] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+8 days after emergence from general anaesthesia with sevoflurane
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| Notes [12] - One participant was excluded after allocation to sevoflurane, and 20 participants completed the arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Grey matter volume, Baseline [13] [14] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Grey matter volume, +4 hours [15] [16] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+4 hours after emergence from general anaesthesia
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| Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Grey matter volume, +1 day [17] [18] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+1 day after general anaesthesia with sevoflurane
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| Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Grey matter volume, +8 days [19] [20] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+8 days after general anaesthesia with sevoflurane
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| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Hippocampus volume, Baseline [21] [22] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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| Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Hippocampus volume, +4 hours [23] [24] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+4 hours after emergence from general anaesthesia
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| Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Hippocampus volume, +1 day [25] [26] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+1 day after general anaesthesia with sevoflurane
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| Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Hippocampus volume, +8 days [27] [28] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+8 days after general anaesthesia with sevoflurane
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| Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Thalamus volume, Baseline [29] [30] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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| Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Thalamus volume, +4 hours [31] [32] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+4 hours after emergence from general anaesthesia with sevoflurane
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| Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Thalamus volume, +1 day [33] [34] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+1 day after emergence from general anaesthesia with sevoflurane
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| Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Thalamus volume, +8 days [35] [36] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+8 days after emergence from general anaesthesia with sevoflurane
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| Notes [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Anterior Cingulate Cortex volume, Baseline [37] [38] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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| Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Anterior Cingulate Cortex volume, +4 hours [39] [40] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+4 hours after emergence from general anaesthesia with sevoflurane
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| Notes [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Anterior Cingulate Cortex volume, +1 day [41] [42] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+1 day after general anaesthesia with sevoflurane
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| Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Sevoflurane, Anterior Cingulate Cortex volume, +8 days [43] [44] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+8 days after general anaesthesia with sevoflurane
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| Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| No statistical analyses for this end point | |||||||||
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End point title |
Propofol, Whole brain volume, Baseline [45] [46] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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| Notes [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| Notes [47] - 22 participants were allocated to propofol, of which 1 was excluded and 21 completed the arm. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Propofol, Whole brain volume, +4 hours [48] [49] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
+4 hours after emergence from general anaesthesia with propofol
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| Notes [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
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| Notes [50] - 22 participants were allocated to propofol, of which 1 was excluded and 21 completed the arm. |
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| No statistical analyses for this end point | |||||||||
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|||||||||
End point title |
Propofol, Whole brain volume, +1 day [51] [52] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+1 day after general anaesthesia with propofol
|
||||||||
| Notes [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| Notes [53] - 22 participants were allocated to propofol, of which 1 was excluded and 21 completed the arm. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Whole brain volume, +8 days [54] [55] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+8 days after general anaesthesia with propofol
|
||||||||
| Notes [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| Notes [56] - 22 participants were allocated to propofol, of which 1 was excluded and 21 completed the arm. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Grey matter volume [57] [58] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Baseline
|
||||||||
| Notes [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Grey matter volume, +4 hours [59] [60] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+4 hours after emergence from general anaesthesia with propofol
|
||||||||
| Notes [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Grey matter volume, +1 day [61] [62] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+1 day after general anaesthesia with propofol
|
||||||||
| Notes [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Grey matter volume, +8 days [63] [64] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+8 days after general anaesthesia with propofol
|
||||||||
| Notes [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Hippocampus volume, Baseline [65] [66] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Baseline
|
||||||||
| Notes [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Hippocampus volume, +4 hours [67] [68] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+4 hours after emergence from general anaesthesia with propofol
|
||||||||
| Notes [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Hippocampus volume, +1 day [69] [70] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+4 hours after emergence from general anaesthesia with propofol
|
||||||||
| Notes [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Hippocampus volume, +8 days [71] [72] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+8 days after general anaesthesia with propofol
|
||||||||
| Notes [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Thalamus volume, Baseline [73] [74] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Baseline
|
||||||||
| Notes [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Thalamus volume, +4 hours [75] [76] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+4 hours after emergence from general anaesthesia with propofol
|
||||||||
| Notes [75] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Thalamus volume, +1 day [77] [78] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+1 day after general anaesthesia with propofol
|
||||||||
| Notes [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Thalamus volume, +8 days [79] [80] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+8 days after general anaesthesia with propofol
|
||||||||
| Notes [79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Anterior Cingulate Cortex volume, Baseline [81] [82] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Baseline
|
||||||||
| Notes [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [82] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Anterior Cingulate Cortex volume, +4 hours [83] [84] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+4 hours after emergence from general anaesthesia with propofol
|
||||||||
| Notes [83] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Anterior Cingulate Cortex volume, +1 day [85] [86] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+1 day after general anaesthesia with propofol
|
||||||||
| Notes [85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Propofol, Anterior Cingulate Cortex volume, +8 days [87] [88] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
+8 days after general anaesthesia with propofol
|
||||||||
| Notes [87] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Optional [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Optional |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||
|
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
Eight days.
|
||||||||||
Assessment type |
Systematic | ||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
None | ||||||||||
Dictionary version |
0
|
||||||||||
|
Reporting groups
|
|||||||||||
Reporting group title |
All participants
|
||||||||||
Reporting group description |
- | ||||||||||
|
|||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
|
|||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The intervention consists of general anaesthesia will well-known medications that have been in use for decades for this purpose: sevoflurane and propofol. No adverse events were reported. |
|||||||||||
|
||||||||||
Substantial protocol amendments (globally) |
||||||||||
| Were there any global substantial amendments to the protocol? No | ||||||||||
Interruptions (globally) |
||||||||||
| Were there any global interruptions to the trial? Yes | ||||||||||
|
||||||||||
Limitations and caveats |
||||||||||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | ||||||||||
| The trial was terminated after 21 instead of 30 participants for logistical reasons. The following results are pending: - Diffusion Tensor Imaging - Resting state functional MRI - Fatigue and wellbeing - Cognitive performance | ||||||||||
Online references |
||||||||||
| http://www.ncbi.nlm.nih.gov/pubmed/32962743 |
||||||||||
