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Completed

NCT Number: NCT03744949

ED50 and ED95 of Remifentanil for Intubation Without NOL Variation

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

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Key information

Conditions

Intubation; Difficult or Failed Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Maisonneuve Rosemont

Montreal East, Quebec, H1T2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

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 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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: in the surgery

    Time in seconds spent above 25 of NOL index and comparison between the 4 doses of remifentanil used in this study

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

    Time frame: in the surgery

    Compare the AUC of NOL after tracheal intubation between the 4 doses of remifentanil used in this study.

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

    Time frame: in the surgery

    To compare maximal heart rate values reached after tracheal intubation between the 4 doses of remifentanil used in this study

  6. Heart Rate variation (DELTA Heart Rate) after tracheal intubation (in beats per minute)

    Time frame: in the surgery

    To compare the DELTA Heart Rate after tracheal intubation between the 4 doses of remifentanil used in this study

  7. Time in seconds that Heart Rate spends above threshold of 10%; in seconds

    Time frame: 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.

  8. Area under the curve of Heart Rate after tracheal intubation (no unit)

    Time frame: in the surgery

    To compare AUC of Heart Rate values after tracheal intubation between teh 4 different doses of remifentanil used in this study.

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study title

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

Acronym: RemiTrach

Important dates

Study start
2018
Primary completion
2018
Study completion
2021
First posted
Nov 19, 2018
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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