Optimum Dose of Remifentanil for Intubation in Small Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00474071
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : September 25, 2008
Information provided by:
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Endotracheal Intubation Drug: Remifentanil Phase 3

Detailed Description:

The introduction of propofol and short acting opioids has allowed intubation without the use of NMBA to become routine practice. The combination of an opioid and propofol reduces laryngeal reflexes and decreases pressor response to intubation. Identification of the optimum dose combination and sequence of remifentanil-propofol for intubation would allow clinicians to abandon the use of non depolarizing muscle relaxants.Younger children may need higher doses of Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant effect of Remifentanil. The Remifentanil dose will be prepared in a standard fashion by an anesthesiologist not directly involved in the study from the data given to them by a research assistant. The anesthesiologists performing laryngoscopy will be one of the four investigators. There will be a standard starting dose, which must be as close to the population mean as possible. All subjects will receive a minimum dose of 1µg/kg remifentanil which has been shown to produce acceptable intubating conditions.

The dose of remifentanil for the following subject in each group will be determined from the dose used in the previous subject and response to intubation using an" up and down" sequential-allocation technique described by Dixon.

The mean remifentanil intubation dose will be obtained by calculating the midpoint concentration of all independent pairs of patients involving a crossover (ie. Intubation scores all1 to intubation scores not all 1). Mean remifentanil intubation dose would be the average of the crossover midpoints in each subgroup. In addition the standard deviation of remifentanil dose will be the standard deviation of the crossover midpoints in each group. Patient demographics (age/sex/weight), and time to return of spontaneous ventilation will be expressed as mean +/- standard deviation. The inter-group comparisons will be performed using analysis of variance with a difference of 0.5 µg/kg considered to be significant and a p<0.05 considered statistically significant.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation to Determine the Optimum Dose of Remifentanil for Tracheal Intubation in Children Using the Up/Down Method
Study Start Date : March 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Remifentanil
    See Detailed Description.

Primary Outcome Measures :
  1. Remifentanil intubation dose for ideal intubating conditions

Secondary Outcome Measures :
  1. Cardiovascular effects. Time to return to spontaneous ventilation.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presenting for routine endotracheal intubation under anesthesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00474071

Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 2V4
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Mark Ansermino, MD University of British Columbia
Study Director: Helen Hume-Smith, MD University of British Columbia
Study Director: Carolyne Montgomery, MD University of British Columbia

Responsible Party: Dr. Mark Ansermino, University of British Columbia Identifier: NCT00474071     History of Changes
Other Study ID Numbers: H06-03467
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: May 2007

Keywords provided by University of British Columbia:
endotracheal intubation

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General