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

Primary Purpose

Spinal Puncture

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Puncture focused on measuring Lumbar Puncture, Pediatrics, Propofol, Remifentanil, sedation, Oncology

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg

Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg

Arm Description

Outcomes

Primary Outcome Measures

Duration of Apnea
Duration of no respiratory effort
Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2006
Last Updated
November 12, 2018
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00405522
Brief Title
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
Official Title
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Puncture
Keywords
Lumbar Puncture, Pediatrics, Propofol, Remifentanil, sedation, Oncology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Arm Type
Experimental
Arm Title
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of Apnea
Description
Duration of no respiratory effort
Time Frame
This outcome was measured for the duration of the procedure (lumbar puncture).
Title
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 Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hayes, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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

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