NCT00213239

Brief Summary

This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
10.6 years until next milestone

Results Posted

Study results publicly available

August 10, 2018

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

September 13, 2005

Results QC Date

November 6, 2017

Last Update Submit

November 18, 2019

Conditions

Hematologic DiseasesNeoplasms

Keywords

spinal punctureremifentanilpropofolanesthesiadose findingpediatrics

Outcome Measures

Primary Outcomes (1)

  • Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion

    Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion

    Movement measured at the time of lumbar puncture needle insertion.

Secondary Outcomes (1)

  • Incidence of Adverse Events.

    Followed for the length of the procedure.

Study Arms (2)

Propofol 4 mg/kg group

EXPERIMENTAL

First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)

Drug: Remifentanil

Propofol 2 mg/kg group

EXPERIMENTAL

First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)

Drug: Remifentanil

Interventions

RemifentanilDRUG

The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.

Propofol 4 mg/kg group

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of a hemato-oncological disorder
  • Scheduled to undergo a lumbar puncture
  • Aged 4-11 years
  • Male or female
  • Unpremedicated
  • Willing and able to provide informed consent (or informed consent by parents)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Hayes JA, Lopez AV, Pehora CM, Robertson JM, Abla O, Crawford MW. Coadministration of propofol and remifentanil for lumbar puncture in children: dose-response and an evaluation of two dose combinations. Anesthesiology. 2008 Oct;109(4):613-8. doi: 10.1097/ALN.0b013e31818629f3.

    PMID: 18813039RESULT

Related Links

MeSH Terms

Conditions

Hematologic DiseasesNeoplasms

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Jason Hayes
Organization
The Hospital for Sick Children, Department of Anesthesia and Pain Medicine
jason.hayes@sickkids.ca
416-813-7654

Study Officials

  • Jason Hayes, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2007

Study Completion

January 1, 2008

Last Updated

December 2, 2019

Results First Posted

August 10, 2018

Record last verified: 2019-11

Locations

CA(1)