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

The Hospital for Sick Children34 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Spinal Puncture

Interventions

Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kgDRUG

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 4.0 mg/kg + Remifentanil 0.5 ug/kgDRUG

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Duration of Apnea

Duration of no respiratory effort

Time frame: This outcome was measured for the duration of the procedure (lumbar puncture).

Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).

Time frame: This outcome was measured for the duration of the recovery phase.

Secondary Outcomes

Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.

Time frame: This outcome was measured for the duration of the procedure (lumbar puncture).

Data from ClinicalTrials.gov

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