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

November 12, 2018 updated by: Jason Hayes, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Drug: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
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.
Experimental: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Drug: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Apnea
Time Frame: This outcome was measured for the duration of the procedure (lumbar puncture).
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).
Time Frame: This outcome was measured for the duration of the recovery phase.
This outcome was measured for the duration of the recovery phase.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000009427

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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