Trial Outcomes & Findings for Propofol for Pediatric Tracheal Intubation With Deep Anesthesia During Sevoflurane Induction (NCT NCT01150838)
NCT ID: NCT01150838
Last Updated: 2021-02-08
Results Overview
Logistic regression utilized to measure the amount of propofol to obtain 50% excellent intubation conditions for each age/time group. The quality of tracheal intubation will be graded according to the Steyn modification of the Helbo-Hansen scoring system for tracheal intubation, which includes evaluation of ease of laryngoscopy, position of the vocal cords, coughing, jaw relaxation and movement of limbs, each evaluated on a 1-4 scale, with 1 being the best possible condition and 4 the worst. The intubation conditions will be classified as either excellent or not-excellent. "Excellent" will be defined as a total score of 5, a score of 1 for each category, and "not-excellent" will be a total score of 6-20, meaning a score of \>1 in any category. While the outcome measure of each intubation is "excellent" or "not excellent", the overall outcome being generated is the amount of propofol in mg/kg required for 50% excellent intubation score.
COMPLETED
PHASE4
106 participants
Amount of time it takes to intubate each patient; approximate time is 15-45 seconds
2021-02-08
Participant Flow
Participants were recruited at an outpatient surgery center
Four patients dropped out due to protocol violations or ended up outside the three time periods by the time IV access obtained.
Participant milestones
| Measure |
Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 6-11 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
26
|
24
|
15
|
16
|
2
|
|
Overall Study
COMPLETED
|
19
|
26
|
24
|
15
|
16
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
No sex/gender data was collected.
Baseline characteristics by cohort
| Measure |
Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration
n=19 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued.
propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
|
Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration
n=26 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued.
propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
|
Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration
n=24 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued.
propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
|
Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration
n=15 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued.
propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
|
Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration
n=16 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued.
propofol: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=19 Participants
|
26 Participants
n=26 Participants
|
24 Participants
n=24 Participants
|
15 Participants
n=15 Participants
|
16 Participants
n=16 Participants
|
100 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
—
|
—
|
0 Participants
No sex/gender data was collected.
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
—
|
—
|
0 Participants
No sex/gender data was collected.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
26 Participants
n=26 Participants
|
24 Participants
n=24 Participants
|
15 Participants
n=15 Participants
|
16 Participants
n=16 Participants
|
100 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Amount of time it takes to intubate each patient; approximate time is 15-45 secondsPopulation: Two patients in Age 6-11 years, 6-8 minutes, did not appear in baseline analysis population due to inadequate numbers collected in that age group and time range to be able to analyze; IV access always achieved earlier that 6 minutes due to ease of IV access.
Logistic regression utilized to measure the amount of propofol to obtain 50% excellent intubation conditions for each age/time group. The quality of tracheal intubation will be graded according to the Steyn modification of the Helbo-Hansen scoring system for tracheal intubation, which includes evaluation of ease of laryngoscopy, position of the vocal cords, coughing, jaw relaxation and movement of limbs, each evaluated on a 1-4 scale, with 1 being the best possible condition and 4 the worst. The intubation conditions will be classified as either excellent or not-excellent. "Excellent" will be defined as a total score of 5, a score of 1 for each category, and "not-excellent" will be a total score of 6-20, meaning a score of \>1 in any category. While the outcome measure of each intubation is "excellent" or "not excellent", the overall outcome being generated is the amount of propofol in mg/kg required for 50% excellent intubation score.
Outcome measures
| Measure |
Age 1-6 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration
n=19 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 1-6 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration
n=26 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 1-6 Years, Time 6-8 Minutes of Sevoflurane Until Propofol Administration
n=24 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 6-11 Years, Time 2-4 Minutes of Sevoflurane Until Propofol Administration
n=15 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
Age 6-11 Years, Time 4-6 Minutes of Sevoflurane Until Propofol Administration
n=16 Participants
Propofol 2 mg/kg administered to first subject. Dose will be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent". Dose will be decreased by 0.3 mg/kg if intubation score is "excellent". This dosing scheme will be continued until at least 6 "crossovers" are achieved.
|
|---|---|---|---|---|---|
|
Estimated Propofol Doses Producing 50% Excellent Intubation Conditions
|
1.48 mg/kg
Interval 0.8 to 2.03
|
0.00 mg/kg
Interval 0.0 to 0.38
|
0.07 mg/kg
Interval 0.0 to 0.68
|
2.35 mg/kg
Interval 1.97 to 2.45
|
2.33 mg/kg
Interval 1.59 to 2.45
|
Adverse Events
Propofol Administration
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place