Trial Outcomes & Findings for Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children (NCT NCT00405522)
NCT ID: NCT00405522
Last Updated: 2019-03-08
Results Overview
Duration of no respiratory effort
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
This outcome was measured for the duration of the procedure (lumbar puncture).
Results posted on
2019-03-08
Participant Flow
Participant milestones
| Measure |
2.0 mg/kg Propofol
Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
4.0 mg/kg Propofol
Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
Baseline characteristics by cohort
| Measure |
2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
4.0 mg/kg Propofol and 0.5 ug/kg Remifentanil
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.2 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.2 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
6.6 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This outcome was measured for the duration of the procedure (lumbar puncture).Duration of no respiratory effort
Outcome measures
| Measure |
2.0 mg/kg Propofol
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
4.0 mg/kg Propofol
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
|---|---|---|
|
Duration of Apnea
|
110 seconds
Interval 0.0 to 228.0
|
73 seconds
Interval 0.0 to 110.0
|
PRIMARY outcome
Timeframe: This outcome was measured for the duration of the recovery phase.Outcome measures
| Measure |
2.0 mg/kg Propofol
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
4.0 mg/kg Propofol
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
|---|---|---|
|
Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).
|
10 minutes
Interval 4.0 to 70.0
|
23 minutes
Interval 5.0 to 69.0
|
SECONDARY outcome
Timeframe: This outcome was measured for the duration of the procedure (lumbar puncture).Outcome measures
| Measure |
2.0 mg/kg Propofol
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
4.0 mg/kg Propofol
n=17 Participants
Propofol + Remifentanil: Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
|
|---|---|---|
|
Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.
|
0 Participants
|
0 Participants
|
Adverse Events
2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4.0 mg/kg Propofol + 0.5 ug/kg Remifentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jason Hayes
The Hospital for Sick Children, Toronto, Ontario, Canada
Phone: 416-813-7654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place