Clinical Trial Results:
The effect of desflurane versus Sevoflurane on postoperative recovery in patients undergoing minor- to moderate-risk noncardiac surgery - a prospective double-blinded randomized clinical trial
Summary
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EudraCT number |
2022-000556-11 |
Trial protocol |
AT |
Global end of trial date |
01 Jun 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Oct 2024
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First version publication date |
18 Oct 2024
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Other versions |
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Summary report(s) |
Publication SAE Report |
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 |
RAPID_01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05331027 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Head Office, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, 0043 4040041020, sekretariat-anaesthesie@meduniwien.ac.at
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Scientific contact |
Head Office, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, 0043 4040041020, sekretariat-anaesthesie@meduniwien.ac.at
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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 |
25 Aug 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Jun 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jun 2023
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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 primary outcome will be the time (in minutes) from discontinuation of volatile anesthetic at the end of surgery until a modified Aldrete score of ≥ 12 points will be reached. We will start to assess postoperative recovery using the modified Aldrete score after arrival at the postoperative care unit (PACU) and thereafter in five minutes intervals. The score consists of 7 modalities (Activity, Respiration, Circulation, Consciousness, Oxygenation, Pain and Emetic Symptoms) with a score of 0-2 points in each criterion.
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Protection of trial subjects |
Patients received desflurane or sevoflurane for general anesthesia. Both anesthetics are commonly used for anesthesia. Thus, there is a low risk for subjects.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Austria: 190
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Worldwide total number of subjects |
190
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EEA total number of subjects |
190
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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) |
0
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From 65 to 84 years |
176
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85 years and over |
14
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Recruitment
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Recruitment details |
Study personnel screened surgical schedule a day before surgery. If patients meeting the inclusion criteria a study physician performed informed consent also a day before surgery. | |||||||||
Pre-assignment
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Screening details |
Patients were eligible if they were at least 65 years undergoing a minor- to moderate-risk noncardiac surgery. | |||||||||
Period 1
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Period 1 title |
Baseline
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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 | |||||||||
Blinding implementation details |
Subjects were not aware of the allocated randomization.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Desflurane | |||||||||
Arm description |
Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Desflurane
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Investigational medicinal product code |
N01AB07
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Other name |
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Pharmaceutical forms |
Inhalation vapour
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Routes of administration |
Inhalation use
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Dosage and administration details |
Maximum of 15% inspiratory concentration %(V/V) percent volume/volume
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Arm title
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Sevoflurane | |||||||||
Arm description |
Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Sevoflurane
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Investigational medicinal product code |
N01AB08
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Other name |
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Pharmaceutical forms |
Inhalation vapour
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Routes of administration |
Inhalation use
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Dosage and administration details |
maximum of 6% inspiratory concentration %(V/V) percent volume/volume
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Period 2
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Period 2 title |
Intraoperative
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
Subject was unaware of the randomly assigned group.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sevoflurane | |||||||||
Arm description |
Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Sevoflurane
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Investigational medicinal product code |
N01AB08
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Other name |
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Pharmaceutical forms |
Inhalation vapour
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Routes of administration |
Inhalation use
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Dosage and administration details |
maximum concentration of 6%, %(V/V) percent volume/volume
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Arm title
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Desflurane | |||||||||
Arm description |
Patients randomly assigned to desflurane received desflurane for general anesthesia. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Desflurane
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Investigational medicinal product code |
N01AB07
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Other name |
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Pharmaceutical forms |
Inhalation vapour
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Routes of administration |
Inhalation use
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Dosage and administration details |
maximum of 15% inspiratory concentration %(V/V) percent volume/volume
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Period 3
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Period 3 title |
Outcome assessment
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind [1] | |||||||||
Roles blinded |
Subject, Assessor | |||||||||
Blinding implementation details |
Outcome assessor and subject were unaware of the randomly assigned group.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Desflurane | |||||||||
Arm description |
Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Desflurane
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Investigational medicinal product code |
N01AB07
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Other name |
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Pharmaceutical forms |
Inhalation vapour
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Routes of administration |
Inhalation use
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Dosage and administration details |
Maximum of 15% inspiratory concentration %(V/V) percent volume/volume
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Arm title
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Sevoflurane | |||||||||
Arm description |
Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Sevoflurane
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Investigational medicinal product code |
N01AB08
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Other name |
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Pharmaceutical forms |
Inhalation vapour
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Routes of administration |
Inhalation use
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Dosage and administration details |
maximum of 6% inspiratory concentration %(V/V) percent volume/volume
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Notes [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial. Justification: Only observer were blinded, treating physicians were not blinded. |
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Baseline characteristics reporting groups
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Reporting group title |
Desflurane
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Reporting group description |
Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sevoflurane
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Reporting group description |
Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Desflurane
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Reporting group description |
Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation. | ||
Reporting group title |
Sevoflurane
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Reporting group description |
Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation. | ||
Reporting group title |
Sevoflurane
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Reporting group description |
Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia. | ||
Reporting group title |
Desflurane
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Reporting group description |
Patients randomly assigned to desflurane received desflurane for general anesthesia. | ||
Reporting group title |
Desflurane
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Reporting group description |
Patients randomly assigned to desflurane received desflurane for mainentance of anesthesia after endotracheal intubation. | ||
Reporting group title |
Sevoflurane
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Reporting group description |
Patients randomly assigned to sevoflurane received sevoflurane for general anesthesia after endotracheal intubation. |
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End point title |
Primary Outcome | ||||||||||||
End point description |
Anesthesia recovery, which was defined as the arrival at the PACU until discharge criteria were reached (Aldrete score more than 12) for a maximum of 2 hours.
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End point type |
Primary
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End point timeframe |
Anesthesia recovery
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Notes [1] - intention-to-treat analysis [2] - intention-to-treat analysis |
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Statistical analysis title |
Primary outcome | ||||||||||||
Statistical analysis description |
For the primary outcome a Wilcoxon-signed rank test was used.
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Comparison groups |
Desflurane v Sevoflurane
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Number of subjects included in analysis |
190
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
first three postoperative days
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Adverse event reporting additional description |
File with SAE was attached.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
23.1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: File with SAE and publication was attached. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/39121786 |