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

Phase 3

Completed

• Conditions: 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

• Registration Number: NCT00405522
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-28
• Study First Submitted QC: 2006-11-28
• Study First Posted: 2006-11-30
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Results First Submitted: 2018-04-16
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-12
• Last Update Submitted: 2018-11-12
• Results First Posted: 2019-03-08
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg	Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg	-
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg	Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg	-

Primary Outcome Measures

Name	Time	Method
Duration of Apnea	This outcome was measured for the duration of the procedure (lumbar puncture).	Duration of no respiratory effort
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

Name	Time	Method
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).

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada