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Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children

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ClinicalTrials.gov Identifier: NCT00405522
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Hayes, The Hospital for Sick Children

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Spinal Puncture
Interventions Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2.0 mg/kg Propofol 4.0 mg/kg Propofol
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 17 17
Completed 17 17
Not Completed 0 0
Arm/Group Title 2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil 4.0 mg/kg Propofol and 0.5 ug/kg Remifentanil Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
6.2  (1.6) 7.2  (2.4) 6.6  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
4
  23.5%
15
  88.2%
19
  55.9%
Male
13
  76.5%
2
  11.8%
15
  44.1%
1.Primary Outcome
Title Duration of Apnea
Hide Description Duration of no respiratory effort
Time Frame This outcome was measured for the duration of the procedure (lumbar puncture).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg/kg Propofol 4.0 mg/kg Propofol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 17 17
Median (Full Range)
Unit of Measure: seconds
110
(0 to 228)
73
(0 to 110)
2.Primary Outcome
Title Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).
Hide Description [Not Specified]
Time Frame This outcome was measured for the duration of the recovery phase.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg/kg Propofol 4.0 mg/kg Propofol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 17 17
Median (Full Range)
Unit of Measure: minutes
10
(4 to 70)
23
(5 to 69)
3.Secondary Outcome
Title Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.
Hide Description [Not Specified]
Time Frame This outcome was measured for the duration of the procedure (lumbar puncture).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0 mg/kg Propofol 4.0 mg/kg Propofol
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Adverse events were observed from the injection of study drugs until discharge from recovery room.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil 4.0 mg/kg Propofol + 0.5 ug/kg Remifentanil
Hide Arm/Group Description 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. 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.
All-Cause Mortality
2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil 4.0 mg/kg Propofol + 0.5 ug/kg Remifentanil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil 4.0 mg/kg Propofol + 0.5 ug/kg Remifentanil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2.0 mg/kg Propofol and 1.5 ug/kg Remifentanil 4.0 mg/kg Propofol + 0.5 ug/kg Remifentanil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jason Hayes
Organization: The Hospital for Sick Children, Toronto, Ontario, Canada
Phone: 416-813-7654 ext 208963
EMail: jason.hayes@sickkids.ca
Layout table for additonal information
Responsible Party: Jason Hayes, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00405522     History of Changes
Other Study ID Numbers: 1000009427
First Submitted: November 28, 2006
First Posted: November 30, 2006
Results First Submitted: April 16, 2018
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019