Clinical trial NCT03744949: ED50 and ED95 of Remifentanil for Intubation Without NOL Variation
Official title: Determination of the ED50 and ED95 of Remifentanil to Perform Tracheal Intubation Without Significant NOL Index Variation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Keywords: Tracheal intubation
Remifentanil
Pain
NOL index
Anesthesia
Analgesia
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four groups of patients. Randomization into the dose of remifentanil given according to a randomization list for a total number of patients of 80.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation
timeFrame: in the surgery
Secondary outcomes:
measure: NOL maximal value after intubation (NOL is an index without unit going from 0 to 100)
timeFrame: in the surgery
measure: Variation of NOL index after tracheal intubation; DELTA NOL (no unit)
timeFrame: in the surgery
measure: Time in seconds NOL spends above 25 after tracheal intubation (in seconds)
timeFrame: in the surgery
measure: Area under the curve for NOL index after tracheal intubation (no unit)
timeFrame: in the surgery
measure: Heart Rate Maximal value after tracheal intubation (in beat per minutes)
timeFrame: in the surgery
measure: Heart Rate variation (DELTA Heart Rate) after tracheal intubation (in beats per minute)
timeFrame: in the surgery
measure: Time in seconds that Heart Rate spends above threshold of 10%; in seconds
timeFrame: in the surgery
measure: Area under the curve of Heart Rate after tracheal intubation (no unit)
timeFrame: in the surgery
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
Study officials:
affiliation: CIUSSS de l'Est de Montreal, Hopital Maisonneuve Rosemont
name: Philippe Richebe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: