Optimum Dose of Remifentanil for Intubation in Small Children
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endotracheal Intubation
Intervention: Remifentanil (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Mark Ansermino, MD, Principal Investigator, Affiliation: University of British Columbia
Helen Hume-Smith, MD, Study Director, Affiliation: University of British Columbia
Carolyne Montgomery, MD, Study Director, Affiliation: University of British Columbia
Overall contact:
Joanne Lim, Phone: 604-875-2000, Ext: 6669, Email: jlim2@cw.bc.ca
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.
Clinical Details
Official title: Investigation to Determine the Optimum Dose of Remifentanil for Tracheal Intubation in Children Using the Up/Down Method
Study design: Treatment, Non-Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Remifentanil intubation dose for ideal intubating conditions
Secondary outcome: Cardiovascular effects. Time to return to spontaneous ventilation.
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.
Eligibility
Minimum age: N/A.
Maximum age: 3 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Presenting for routine endotracheal intubation under anesthesia.
Locations and Contacts
Joanne Lim, Phone: 604-875-2000, Ext: 6669, Email: jlim2@cw.bc.ca
BC Children's Hospital, Vancouver, British Columbia V6H 2V4, Canada; Recruiting
Joanne Lim, Phone: 604-875-2000, Ext: 6669, Email: jlim2@cw.bc.ca
Additional Information
Starting date: March 2007
Ending date: April 2008
Last updated: May 15, 2007
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