Clinical Trial Results:
A psychomotor recuperation study after deep sedation for colonoscopy between target controlled and manual titration of propofol.
Summary
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EudraCT number |
2014-005215-16 |
Trial protocol |
BE |
Global end of trial date |
21 Feb 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2021
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First version publication date |
29 Jul 2021
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Other versions |
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 |
CHUB-MentalRecup001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02314559 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
CHU Brugmann
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Sponsor organisation address |
4 Place A. Van Gehuchten, Brussels, Belgium, 1020
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Public contact |
Anesthesiology Service , CHU Brugmann, 32 024773996, Philippe.VANDERLINDEN@chu-brugmann.be
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Scientific contact |
Anesthesiology Service , CHU Brugmann, 32 024773996, Philippe.VANDERLINDEN@chu-brugmann.be
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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 |
21 Feb 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Feb 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Feb 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Our aim is to evaluate efficacy and recovery after manual titration and target controlled infusion (TCI) of propofol, during colonoscopy, for ambulatory patients. We will evaluate both groups during and after colonoscopy for adverse events, quality of sedation and recovery of psychomotor function.
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Protection of trial subjects |
The study followed the standard of care regarding pain mangement.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Feb 2015
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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 |
Belgium: 154
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Worldwide total number of subjects |
154
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EEA total number of subjects |
154
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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) |
109
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From 65 to 84 years |
45
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
184 patients were assessed for eligibility. 164 patients were randomized. 10 patients were excluded (withdrew consent, modified procedures, cancelled procedures and technical problems, hospitalizations). 154 patients were analyzed. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Assessor, Investigator | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Bolus group | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Propofol 10mg/ml (Diprivan)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
10mg/ml, intravenous administration.
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Arm title
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TCI Group | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Propofol 10mg/ml (Diprivan)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
10mg/ml, intravenous administration.
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Baseline characteristics reporting groups
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Reporting group title |
Bolus group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TCI Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bolus group
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Reporting group description |
- | ||
Reporting group title |
TCI Group
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Reporting group description |
- |
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End point title |
Differences in 'fit for discharge' time | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
up to 60 minutes after colonoscopy cessation
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Statistical analysis title |
Mann-Whitney UTest | |||||||||
Comparison groups |
Bolus group v TCI Group
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Number of subjects included in analysis |
154
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Overall trial
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Clinical Practice | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
N/A
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Reporting groups
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Reporting group title |
Bolus group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TCI Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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25 Apr 2016 |
Change of principal investigator and increase of trial duration |
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29 May 2017 |
Increase of trial duration |
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24 Apr 2018 |
Increase of trial duration |
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27 Aug 2018 |
Principal investigator change and increase of trial duration |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |