NCT00474071

Brief Summary

The routine medications to relax the muscles of the throat are an anesthetic drug, propofol, in combination with an ultra short acting pain medicine, remifentanil. Remifentanil is used to reduce the amount of propofol required but also to decrease the natural cough reflex to the breathing tube being inserted.The purpose of this study is to find the dose of remifentanil when combined with propofol which provides the best conditions for intubation without cough in infants and small children.Younger children may need higher doses of Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant effect of Remifentanil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

May 1, 2007

Enrollment Period

1.1 years

First QC Date

May 14, 2007

Last Update Submit

September 24, 2008

Conditions

Endotracheal Intubation

Keywords

Remifentanilendotracheal intubationpediatrics

Outcome Measures

Primary Outcomes (1)

  • Remifentanil intubation dose for ideal intubating conditions

Secondary Outcomes (1)

  • Cardiovascular effects. Time to return to spontaneous ventilation.

Interventions

RemifentanilDRUG

See Detailed Description.

Eligibility Criteria

AgeUp to 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Presenting for routine endotracheal intubation under anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 2V4, Canada

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mark Ansermino, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Helen Hume-Smith, MD

    University of British Columbia

    STUDY DIRECTOR

  • Carolyne Montgomery, MD

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 16, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 25, 2008

Record last verified: 2007-05

Locations

CA(1)