Clinical Trial Results:
Postoperative pain after anesthesia: propofol vs. sevoflurane
Summary
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EudraCT number |
2009-011038-82 |
Trial protocol |
AT |
Global end of trial date |
13 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Apr 2021
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First version publication date |
02 Apr 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 |
20080926
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Währinger Gürtel 18-20, Vienn, Austria, 1090
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Public contact |
Univ.Klinik f. Anästhesie u. Allgem. Intensivmedizin, Medizinsche Universität Wien, 0043 140400,
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Scientific contact |
Univ.Klinik f. Anästhesie u. Allgem. Intensivmedizin, Medizinsche Universität Wien, 0043 140400,
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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 |
13 Mar 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Mar 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Mar 2014
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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 |
patient´s pain according to VAS score
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Protection of trial subjects |
No painful or distressing examinations were done.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Nov 2010
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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 |
Austria: 90
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Worldwide total number of subjects |
90
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EEA total number of subjects |
90
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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) |
90
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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 |
Patients undergoing open vein stripping surgery were randomized to either sevoflurane or propofol anesthesia. | |||||||||
Pre-assignment
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Screening details |
Participants were 18-75 yrs old, ASA 1-3 and had no history of chronic pain or allergies to morphine and derivates.All patients were capable of giving consent | |||||||||
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 |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Propofol | |||||||||
Arm description |
- | |||||||||
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 |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
propofol at 3-5 mg!kg than in operfusor 2,5-3 mg!kg per hour
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Arm title
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Sevoflurane | |||||||||
Arm description |
- | |||||||||
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 solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
5-6% than 1,5-2,5% in ear
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Propofol
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Reporting group description |
- | ||
Reporting group title |
Sevoflurane
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Reporting group description |
- |
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End point title |
Postoperative opiod consumption | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
after operation with pump
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Statistical analysis title |
post operation pain | ||||||||||||
Comparison groups |
Propofol v Sevoflurane
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.5 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
side effect : vomiting
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17.0
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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: there was no serious adverse events |
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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 |