Trial Outcomes & Findings for Optimal Sevoflurane Concentration for Intubation in Combination of Clincal Remifentanil Doses (NCT NCT02440204)
NCT ID: NCT02440204
Last Updated: 2019-01-17
Results Overview
Sevoflurane concentration used to perform intubation (For ED50 finding)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
During the induction of anesthesia
Results posted on
2019-01-17
Participant Flow
Participant milestones
| Measure |
Remifentanil 1.0 mcg/kg
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 1.5 mcg/kg
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 2.0 mcg/kg
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
22
|
|
Overall Study
COMPLETED
|
22
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Remifentanil 1.0 mcg/kg
n=22 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 1.5 mcg/kg
n=24 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 2.0 mcg/kg
n=22 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
24 Participants
n=24 Participants
|
22 Participants
n=22 Participants
|
68 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=68 Participants
|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 1.7 • n=22 Participants
|
21.3 years
STANDARD_DEVIATION 1.6 • n=24 Participants
|
21.5 years
STANDARD_DEVIATION 2.2 • n=22 Participants
|
21.3 years
STANDARD_DEVIATION 1.7 • n=68 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=22 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=22 Participants
|
24 Participants
n=24 Participants
|
22 Participants
n=22 Participants
|
68 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
22 participants
n=22 Participants
|
24 participants
n=24 Participants
|
22 participants
n=22 Participants
|
68 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: During the induction of anesthesiaSevoflurane concentration used to perform intubation (For ED50 finding)
Outcome measures
| Measure |
Remifentanil 1.0 mcg/kg
n=22 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 1.5 mcg/kg
n=24 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 2.0 mcg/kg
n=22 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
|---|---|---|---|
|
EC50 for Successful Intubation in Each Groups
|
3.00 vol%
Interval 2.36 to 3.18
|
2.00 vol%
Interval 1.38 to 2.54
|
1.29 vol%
Interval 1.14 to 1.5
|
SECONDARY outcome
Timeframe: During the induction of anesthesiaSevoflurane concentration used to perform intubation (For ED95 finding)
Outcome measures
| Measure |
Remifentanil 1.0 mcg/kg
n=22 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 1.5 mcg/kg
n=24 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 2.0 mcg/kg
n=22 Participants
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
|---|---|---|---|
|
EC95 for Successful Intubation
|
3.45 vol%
Interval 3.0 to 3.47
|
2.91 vol%
Interval 2.35 to 2.95
|
1.89 vol%
Interval 1.47 to 1.95
|
Adverse Events
Remifentanil 1.0 mcg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Remifentanil 1.5 mcg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Remifentanil 2.0 mcg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Remifentanil 1.0 mcg/kg
n=22 participants at risk
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 1.5 mcg/kg
n=24 participants at risk
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
Remifentanil 2.0 mcg/kg
n=22 participants at risk
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Intubation: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil: After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
Sevoflurane: The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/22
|
4.2%
1/24 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Closed vocal cords
|
4.5%
1/22 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place