ED50 and ED95 of Remifentanil for Intubation Without NOL Variation

NCT03744949 | Completed DMC

• 1 other identifier: 2018-1410
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Intubation; Difficult or Failed

Keywords

Tracheal intubation; Remifentanil; Pain; NOL index; Anesthesia; Analgesia

Outcome Measures

Primary Outcomes (1)

• determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation

  The primary goal of this study is to determine the ED95 of remifentanil bolus to perform tracheal intubation without NOL index varying over 20 (peak maximal value of 20) using the Macintosh blade when obtaining a Cormack-Lehane grade I or II of intubation in anesthetized patients (the size of the blade will be chosen according to patient characteristics described in the user's manual for each blade and published in previous literature). This primary outcome will be expressed in mcg/kg of remifentanil.

  in the surgery

Secondary Outcomes (8)

• NOL maximal value after intubation (NOL is an index without unit going from 0 to 100)

  in the surgery

• Variation of NOL index after tracheal intubation; DELTA NOL (no unit)

  in the surgery

• Time in seconds NOL spends above 25 after tracheal intubation (in seconds)

  in the surgery

• Area under the curve for NOL index after tracheal intubation (no unit)

  in the surgery

• Heart Rate Maximal value after tracheal intubation (in beat per minutes)

  in the surgery

Study Arms (4)

Remifentanil dose 0.5 ug/kg

EXPERIMENTAL

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.

Drug: Remifentanil dose 0.5 ug/kg

Remifentnil dose 1 ug/kg

EXPERIMENTAL

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.

Drug: Remifentanil dose 1 ug/kg

Remifentanil dose 1.5 ug/kg

EXPERIMENTAL

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.

Drug: Remifentanil dose 1.5 ug/kg

Remifentanil dose 2 ug/kg

EXPERIMENTAL

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.

Drug: Remifentanil dose 2 ug/kg

Interventions

Remifentanil dose 0.5 ug/kg DRUG

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

Remifentanil dose 0.5 ug/kg

Remifentanil dose 1 ug/kg DRUG

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

Remifentnil dose 1 ug/kg

Remifentanil dose 1.5 ug/kg 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 1.5 ug/kg

Remifentanil dose 2 ug/kg DRUG

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

Remifentanil dose 2 ug/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Hopital Maisonneuve Rosemont

Montreal East, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Philippe Richebe, MD PhD

  CIUSSS de l'Est de Montreal, Hopital Maisonneuve Rosemont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: remifentanil will be given by a dosage of 0.5-1.0-1.5-2.0 µg/kg of adjusted body weight bolus according to randomization, by an infusion pump over 30 seconds
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research in the Department of Anesthesiology

Model Details: Four groups of patients. Randomization into the dose of remifentanil given according to a randomization list for a total number of patients of 80.

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 19, 2018
• Study Start: March 14, 2018
• Primary Completion: October 19, 2018
• Study Completion: September 30, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)