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| Sponsored by: |
University of British Columbia |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00474071 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endotracheal Intubation |
Drug: Remifentanil |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Investigator), Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Investigation to Determine the Optimum Dose of Remifentanil for Tracheal Intubation in Children Using the Up/Down Method |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 3 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Canada, British Columbia | |
| BC Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 2V4 | |
| 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 |
More Information
| Responsible Party: | University of British Columbia ( Dr. Mark Ansermino ) |
| Study ID Numbers: | H06-03467 |
| Study First Received: | May 14, 2007 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00474071 |
| Health Authority: | Canada: Health Canada |
|
Remifentanil endotracheal intubation pediatrics |
|
Remifentanil |
|
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Pharmacologic Actions Sensory System Agents Anesthetics, General |
Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
