ED50 and ED95 of Remifentanil for Intubation Without NOL Variation

Intubation; Difficult or Failed Clinical Trial

— RemiTrach  

Official title:

Determination of the ED50 and ED95 of Remifentanil to Perform Tracheal Intubation Without Significant NOL Index Variation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744949
• Other study ID #: 2018-1410
• Status: Completed
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2021
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Drug:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Canada	Hopital Maisonneuve Rosemont	Montréal-Est	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NOL maximal value after intubation (NOL is an index without unit going from 0 to 100)	After tracheal intubation NOL index maximal value will be evaluated and compared between the 4 doses of remifentanil in mcg/kg received in this study.	in the surgery
Secondary	Variation of NOL index after tracheal intubation; DELTA NOL (no unit)	After tracheal intubation DELTA NOL index will be evaluated and compared between the 4 doses of remifentanil in mcg/kg received in this study.	in the surgery
Secondary	Time in seconds NOL spends above 25 after tracheal intubation (in seconds)	Time in seconds spent above 25 of NOL index and comparison between the 4 doses of remifentanil used in this study	in the surgery
Secondary	Area under the curve for NOL index after tracheal intubation (no unit)	Compare the AUC of NOL after tracheal intubation between the 4 doses of remifentanil used in this study.	in the surgery
Secondary	Heart Rate Maximal value after tracheal intubation (in beat per minutes)	To compare maximal heart rate values reached after tracheal intubation between the 4 doses of remifentanil used in this study	in the surgery
Secondary	Heart Rate variation (DELTA Heart Rate) after tracheal intubation (in beats per minute)	To compare the DELTA Heart Rate after tracheal intubation between the 4 doses of remifentanil used in this study	in the surgery
Secondary	Time in seconds that Heart Rate spends above threshold of 10%; in seconds	To compare the time in seconds between the 4 doses of remifentanil that Heart Rate spends above teh threshold of 10% of variation above normal prestimulus values.	in the surgery
Secondary	Area under the curve of Heart Rate after tracheal intubation (no unit)	To compare AUC of Heart Rate values after tracheal intubation between teh 4 different doses of remifentanil used in this study.	in the surgery