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Optimum Dose of Remifentanil for Intubation in Small Children

Investigation to Determine the Optimum Dose of Remifentanil for Tracheal Intubation in Children Using the Up/Down Method

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00474071
Enrollment
60
Registered
2007-05-16
Start date
2007-03-31
Completion date
2008-04-30
Last updated
2008-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation

Keywords

Remifentanil, endotracheal intubation, pediatrics

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.

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.

Interventions

DRUGRemifentanil

See Detailed Description.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Weeks
Healthy volunteers
No

Inclusion criteria

* Presenting for routine endotracheal intubation under anesthesia.

Design outcomes

Primary

MeasureTime frame
Remifentanil intubation dose for ideal intubating conditions

Secondary

MeasureTime frame
Cardiovascular effects. Time to return to spontaneous ventilation.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026