Clinical Trial Results:
Does isocapnic hyperventilation hasten early recovery with sevoflurane and desflurane in O2/air?
Summary
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EudraCT number |
2014-000678-20 |
Trial protocol |
BE |
Global end of trial date |
06 Aug 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
04 May 2025
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First version publication date |
04 May 2025
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Other versions |
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Summary report(s) |
article study |
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 |
SEVODESHV
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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 |
UZ Brussel
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Sponsor organisation address |
Laarbeeklaan 101, 1090, Belgium,
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Public contact |
Datanurse, UZ Brussel, +32 24763134, veerle.vanmossevelde@uzbrussel.be
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Scientific contact |
Datanurse, UZ Brussel, +32 24763134, veerle.vanmossevelde@uzbrussel.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 |
17 Apr 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Apr 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Aug 2024
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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 |
The goal of the study is to examine the effect of hyperventilation on early recovery parameters when sevoflurane or desflurane is used. CO2 will be added to the inspired gas to avoid hypocapnia (“isocapnic hyperventilation”)
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Protection of trial subjects |
Trial subjects were closely monitored through the whole study conduct as from signing the informed consent.
If heart rate or blood pressure increased 20% above baseline (immediate pre‐induction values) or systolic blood pressure increased above 140 mm Hg, Ce remifentanil was increased. Hypotension (systolic blood pressure ≤80 mm Hg) was treated by decreasing the Ce remifentanil (with a 1.5 ng/mL lower limit), additional fluid administration, and by intravenous phenylephrine or ephedrine, depending on the prevailing heart rate.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Feb 2014
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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: 34
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Worldwide total number of subjects |
34
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EEA total number of subjects |
34
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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) |
34
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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 |
- | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
34 | |||||||||
Number of subjects completed |
25 | |||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
no data captured: 9 | |||||||||
Period 1
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Period 1 title |
study conduct (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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Normoventilation group | |||||||||
Arm description |
- | |||||||||
Arm type |
SOC Group | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Isocapnic hyperventilation group | |||||||||
Arm description |
- | |||||||||
Arm type |
test group | |||||||||
Investigational medicinal product name |
Respiratory rate
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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 |
Unknown use
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Dosage and administration details |
respiratory rate was doubled for this group after anesthesia was stopped.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 34 patients were enrolled (ICF signed) in the study. However 9 patients were lost due to failed data retrieval during surgery/anesthesia. |
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Baseline characteristics reporting groups
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Reporting group title |
Normoventilation group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Isocapnic hyperventilation group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Normoventilation group
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Reporting group description |
- | ||
Reporting group title |
Isocapnic hyperventilation group
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Reporting group description |
- |
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End point title |
time to proper response to verbal command | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Time from the beginning of emergence to proper response to verbal command.
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
time to ETT removal | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Time from the beginning of emergence to ETT removal
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
Time to stating name | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Time from the beginning of emergence to state name
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
Fa sevoflurane at T(eye) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
partial pressure of sevoflurane at time to proper respond to verbal command.
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
Fa sevo at T(ETT) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
partial pressure of sevoflurane at time to ETT removal.
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
Fa sevo T(name) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
partial pressure of sevoflurane at time to stating name
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
Fa CO2 at T(eye) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
partial pressure of CO2 at time to proper respond to verbal command.
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
Fa CO2 at T(ETT) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
partial pressure of CO2 at time to ETT removal
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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End point title |
Fa CO2 at T(name) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
partial pressure of CO2 at time to state name
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Statistical analysis title |
ANOVA + t-test | ||||||||||||
Comparison groups |
Normoventilation group v Isocapnic hyperventilation group
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Number of subjects included in analysis |
25
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
adverse events were to be reported as from signing the ICF till the time after surgery the patient could state their name. At that time point, the end of study was reached for every patient.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
22
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Reporting groups
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Reporting group title |
study conduct
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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: No adverse events were reported because the study ended for the patient after they could state their name after surgery. On average this was 11-12 minutes after emergence. |
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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 |