Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00474071
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2007-05-14
Brief Title:
Optimum Dose of Remifentanil for Intubation in Small Children
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Investigation to Determine the Optimum Dose of Remifentanil for Tracheal Intubation in Children Using the UpDown Method
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 insertedThe 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 childrenYounger children may need higher doses of Remifentanil to facilitate intubation as they are more tolerant to the respiratory depressant effect of Remifentanil
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 relaxantsYounger 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 1µgkg 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 agesexweight 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 05 µgkg considered to be significant and a p005 considered statistically significant
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 agesexweight 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 05 µgkg considered to be significant and a p005 considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None