ED50 and ED95 of Remifentanil for Intubation Without NOL Variation

NCT ID: NCT03744949

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-14
• Study Completion Date: 2021-09-30

Brief Summary

Our aim, in this study, is to elucidate the optimal dosing range (ED50 and ED95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the NOL index. In order to maximize the clinical relevance of our findings, induction of general anesthesia will be done with standard medications and doses and laryngoscopy will be done with the Macintosh laryngoscope, the most common tool used for intubation in the operating room

Detailed Description

Background: There are no study so far that determined the ED50 and ED95 of remifentanil to perform tracheal intubation by using the NOL index as the criterion measured to determine the failure (painful intubation) or the success (pain free intubation) of the assessed procedure.

Objectives: To determine the ED50 and ED95 of remifentanil bolus to perform tracheal intubation without NOL index variating over threshold for nociceptive response (determined as a NOL index going over 20 - peak value of maximum 20) using the Macintosh blade when obtaining good conditions of intubation in anesthetized patients. Good conditions of intubation will be determined as obtaining a Cormack-Lehane grade I and II.

Conditions

Intubation; Difficult or Failed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Remifentanil dose 0.5 ug/kg

Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.

Group Type: EXPERIMENTAL

Remifentanil dose 0.5 ug/kg

Intervention Type: DRUG

Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Remifentnil dose 1 ug/kg

Remifentanil will be given (dosage of 1.0 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.

Group Type: EXPERIMENTAL

Remifentanil dose 1 ug/kg

Intervention Type: DRUG

Remifentanil will be given (dosage of 1 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Remifentanil dose 1.5 ug/kg

Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.

Group Type: EXPERIMENTAL

Remifentanil dose 1.5 ug/kg

Intervention Type: DRUG

Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Remifentanil dose 2 ug/kg

Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus according to randomization) from an infusion pump over 30 seconds. The bolus of remifentanil will be programmed on an electronic pump which gives an auditory signal when each bolus is completed. When the pump will ring at the end of the remifentanil bolus, the chronometer on the Dräger Monitor (anesthesia machine, Dräger Perseus A500, Draeger Medical Canada Inc., Ontario, Canada) will be turned on.

Group Type: EXPERIMENTAL

Remifentanil dose 2 ug/kg

Intervention Type: DRUG

Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Interventions

Remifentanil dose 0.5 ug/kg

Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Intervention Type: DRUG

Remifentanil dose 1 ug/kg

Remifentanil will be given (dosage of 1 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Intervention Type: DRUG

Remifentanil dose 1.5 ug/kg

Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Intervention Type: DRUG

Remifentanil dose 2 ug/kg

Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ASA status I or II
• Mallampati class I or II
• Patients > 18 years old and <65 years (defining elderly patients)
• Elective general, gynecological, orthopedic, plastic or urological surgery under general anesthesia
• Type of surgery that usually necessitate endotracheal intubation and controlled ventilation

Exclusion Criteria

• Patient refusal
• History of psychiatric diseases or psychological problems (including mental retardation); inability to give consent; language barrier.
• Anticipated difficult airway (Mallampati class III and IV, thyromental distance < 6 cm, mouth opening < 3 cm, neck extension <80° and neck flexion <35°, inability to prognath, meaning bringing lower mandibular before the upper maxilla)
• Patient with history of neck rigidity or instability
• BMI > 30 kg/m2
• Anticipated difficult ventilation (patients with beard, obesity with BMI more than 30 kg/m2)
• Patient with history of oropharyngeal or tracheal surgery (excluding adenoidectomy, tonsillectomy and teeth removal)
• Severe coronary artery disease
• Serious cardiac arrhythmias (including atrial fibrillation)
• Use of β-blockers (all types)
• History of opioid or illicit drug substance abuse
• Chronic use of psychotropic and/or opioid drugs
• Allergy to remifentanil or propofol
• Pregnancy
• Contraindications to mask ventilation (gastrointestinal tract obstruction, pregnancy, active not-treated gastroesophageal reflux disease, non-fasting patients)
• Unexpected difficult airway requesting excessive, possibly painful airway manipulations
• Requiring hemodynamic support with vasopressors or inotropes 2 min before laryngoscopy to 5 min after insertion of endotracheal tube

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Philippe Richebe

Director of Research in the Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Richebe, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CIUSSS de l'Est de Montreal, Hopital Maisonneuve Rosemont

Locations

Hopital Maisonneuve Rosemont

Montreal East, Quebec, Canada

Countries

Canada

Other Identifiers

2018-1410

Identifier Type: -

Identifier Source: org_study_id