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Search / Trial NCT03744949

ED50 and ED95 of Remifentanil for Intubation Without NOL Variation

Launched by CIUSSS DE L'EST DE L'ÎLE DE MONTRÉAL · Nov 14, 2018

Trial Information

Current as of June 18, 2025

Completed

Keywords

Tracheal Intubation Remifentanil Pain Nol Index Anesthesia Analgesia

ClinConnect Summary

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 anesthetiz...

Gender

ALL

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

About Ciusss De L'est De L'île De Montréal

Ciusss de l'Est de l'Île de Montréal is a leading healthcare organization dedicated to enhancing the health and well-being of the communities it serves. As a prominent clinical trial sponsor, Ciusss de l'Est conducts innovative research aimed at advancing medical knowledge and improving patient outcomes. With a focus on collaboration and ethical standards, the organization fosters a multidisciplinary approach to clinical research, ensuring rigorous methodologies and comprehensive patient care. Through its commitment to scientific excellence and community health, Ciusss de l'Est plays a vital role in shaping the future of healthcare in the region.

Locations

Montréal Est, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Philippe Richebe, MD PhD

Principal Investigator

CIUSSS de l'Est de Montreal, Hopital Maisonneuve Rosemont

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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