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

Study Overview
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Brief Summary
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The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Detailed Description
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Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Official Title
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Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations

Conditions
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Spinal Puncture

Intervention / Treatment
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* Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
* Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of a hemato-oncological disorder Scheduled to undergo a lumbar puncture Aged 3-12 years Unpremedicated Exclusion Criteria: children who are known or suspected to be difficult to ventilate by face mask children who are deemed medically unfit to receive either of the two study medications children who are obese (weight for height > 95th percentile) children who do not have an indwelling intravenous line

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg<br> | Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg<br>* 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.<br>|
| Experimental: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg<br> | Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Apnea | Duration of no respiratory effort | This outcome was measured for the duration of the procedure (lumbar puncture). | 
| Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement). |  | This outcome was measured for the duration of the recovery phase. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter. |  | This outcome was measured for the duration of the procedure (lumbar puncture). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Puncture, Pediatrics, Propofol, Remifentanil, sedation, Oncology