Clinical Trial Results:
The effect of pregabalin on the minimal alveolar concentration of
sevoflurane
Summary
|
|
EudraCT number |
2017-001439-37 |
Trial protocol |
AT |
Global end of trial date |
25 Feb 2021
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
07 May 2023
|
First version publication date |
07 May 2023
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
MACSevoPregabalin
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Medical University of Vienna
|
||
Sponsor organisation address |
Waehringer Guertel 18-20, Vienna, Austria, 1090
|
||
Public contact |
Department of General Anaesthesia, Medical University of Vienna, thomas.hamp@meduniwien.ac.at
|
||
Scientific contact |
Department of General Anaesthesia, Medical University of Vienna, thomas.hamp@meduniwien.ac.at
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Feb 2021
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
25 Feb 2021
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
25 Feb 2021
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
This study aims to investigate the effect of clinically used doses of
Pregabalin on the minimum alveolar concentration of sevoflurane to
provide more information to clinicians using this adjunctive drug in the
perioperative setting.
|
||
Protection of trial subjects |
It was made sure that participants were thoroughly informed about trial procedures. Additionally, it was made sure that they were not part of another trial that might coincide.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Oct 2019
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Austria: 78
|
||
Worldwide total number of subjects |
78
|
||
EEA total number of subjects |
78
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
78
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||
Recruitment details |
The operation schedule for the following day was checked and suitable patients identified. They were then asked to participate in the study, one day prior to their inclusion. | ||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||
Screening details |
The patients medical files were checked to make sure they matched the inclusion criteria. | ||||||||||||||||||||
Period 1
|
|||||||||||||||||||||
Period 1 title |
Main period (overall period)
|
||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | ||||||||||||||||||||
Blinding implementation details |
See study protocol section 4.1
|
||||||||||||||||||||
Arms
|
|||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||
Arm title
|
Placebo | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||
Investigational medicinal product name |
Placebo
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Capsule, hard
|
||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||
Dosage and administration details |
150mg placebo were administered at least one hour before anaesthesia orally
|
||||||||||||||||||||
Arm title
|
Pregabalin 150mg | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Pregabalin 150mg
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Capsule, hard
|
||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||
Dosage and administration details |
150mg pregabalin were administered at least one hour before anaesthesia orally
|
||||||||||||||||||||
Arm title
|
Pregabalin 300mg | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Pregabalin 300mg
|
||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||
Other name |
|||||||||||||||||||||
Pharmaceutical forms |
Capsule, hard
|
||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||
Dosage and administration details |
300mg pregabalin were administered at least one hour before anaesthesia orally
|
||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pregabalin 150mg
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pregabalin 300mg
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Placebo
|
||
Reporting group description |
- | ||
Reporting group title |
Pregabalin 150mg
|
||
Reporting group description |
- | ||
Reporting group title |
Pregabalin 300mg
|
||
Reporting group description |
- |
|
|||||||||||||||||
End point title |
minimum alveolar concentration | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
beginning until 15 minutes after beginning of anaesthesia
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Comparison of minimum alveolar concentrations | ||||||||||||||||
Statistical analysis description |
The primary endpoint was the MAC of sevoflurane in the three study groups. The MAC values of the sevoflurane concentration of the three groups were estimated using isotonic regression methods
|
||||||||||||||||
Comparison groups |
Placebo v Pregabalin 150mg v Pregabalin 300mg
|
||||||||||||||||
Number of subjects included in analysis |
78
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [1] | ||||||||||||||||
P-value |
= 0.05 [2] | ||||||||||||||||
Method |
isotonic regression methods | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Notes [1] - The primary endpoint was the MAC of sevoflurane in the three study groups. The MAC values of the sevoflurane concentration of the three groups were estimated using isotonic regression methods [2] - not applicable |
|
|||
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
Begin of trial till 24h after.
|
||
Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
24.1
|
||
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: There are no adverse events in this study. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |