RemiTrach: ED50 and ED95 of Remifentanil for Intubation Without NOL Variation

Sponsor

Ciusss de L'Est de l'Île de Montréal (Other)

Overall Status

Completed

CT.gov ID

NCT03744949

Collaborator

(none)

Enrollment

Location

Arms

42.6

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intubation; Difficult or Failed	Drug: Remifentanil dose 0.5 ug/kg Drug: Remifentanil dose 1 ug/kg Drug: Remifentanil dose 1.5 ug/kg Drug: Remifentanil dose 2 ug/kg	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 14, 2018

Actual Primary Completion Date :

Oct 19, 2018

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
Experimental: 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.	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
Experimental: 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.	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
Experimental: 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.	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

Outcome Measures

Primary Outcome Measures

determine ED95 of remifentanil bolus in mcg/kg for tracheal intubation [in the surgery]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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