Skip to main content
OpenTrials
Completed

NCT Number: NCT05026125

Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients

This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents.

During the induction of general anesthesia, Propofol - Remifentanil combination will be used.

The patients will be randomized in 2 groups with different doses of Remifentanil.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital University of Toulouse

Toulouse, France

About this study

The prevalence of obesity increases steadily. For anesthesiologists, the airway management of obese patients is known to be difficult and at risk. Tracheal intubation needs to be successful quickly. Neuromuscular blocking agents allow this option but with a risk of anaphylaxis and respiratory complications. In fact, for many surgical procedures those drugs are not necessary.

Numerous studies in non-obese patients with the combination of Remifentanil and Propofol have shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. This combination has never been studied in obese patient.

After randomization, induction of general anesthesia will be performed with 2,5 mg/kg of Propofol in association with either 3 µg/kg of Ideal Body Weight of Remifentanil, or 3 µg/kg + 30% of Ideal Body Weight of Remifentanil.

Minutes after the induction, orotracheal intubation will be performed, and the Intubation Difficulty Scale recorded.

Other data on hemodynamic, respiratory and airway management will be are collected during the surgery.

In the Post Anaesthetic Care Unit (PACU),Any symptoms of traumatic airway management or aspiration are collected.

Those data will be again looked for and collected on the day of the patient's discharge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient over 18 and under 60 years old.
  • ASA score ≤ 3
  • Elective bariatric surgery for patient with BMI between 35 and 60 or elective revision of a bariatric surgery for patient with a BMI over 30.
  • Patient with a written consent obtained with accurate information.

Exclusion criteria

  • Patient with risk of aspiration
  • Difficult airway known (Cormack score 3 ou 4).
  • Opioids addiction.
  • Alcoholism
  • Chronic use of Opioids
  • Confirmed Allergy to Propofol or Remifentanil
  • Severe chronic hepatic, kidney or respiratory failure
  • Patient already enrolled in another clinical study interfering with this study.

Treatment and study plan

Remifentanil Injection

Drug

Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery

Other names: orotracheal intubation, anesthesia, bariatric surgery

Remifentanil Injection plus 30%

Drug

Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery

Other names: orotracheal intubation, anesthesia, bariatric surgery

Primary outcomes

  1. percentage of patients with excellent conditions of intubation

    Time frame: Baseline

    Intubation conditions will be assessed using the intubation conditions score proposed by Viby-Mogensen and al. (Scandinavian score). The score defines intubation conditions: excellent (all variables are excellent), good (all variables are either excellent or good), or poor (presence of a poor variable).

Secondary outcomes

  1. Hemodynamic effects : hypotension

    Time frame: Baseline

    Percentage of patients with arterial hypotension (>20% decrease in mean arterial pressure) within 40 minutes of intubation

  2. Hemodynamic effects: bradycardia

    Time frame: Baseline

    Percentage of patients with bradycardia (>20% decrease in heart rate) within 40 minutes after intubation

  3. Hemodynamic effects: use of vasopressor drugs

    Time frame: Baseline

    Number of times vasopressor drugs were used.after intubation

  4. Respiratory effects: patients with desaturation day 0

    Time frame: Baseline

    Percentage of patients with desaturation (pulse oximetry (SpO2) below 90%.)

  5. Respiratory effects: patients with aspiration

    Time frame: From Baseline to day 2

    Percentage of patients with aspiration (defined by the existence of gastric fluid in the oropharynx during direct laryngoscopy or by the diagnosis of pneumopathy within 48 hours of surgery).

  6. Intubation complexity

    Time frame: Baseline

    Intubation complexity Measured by Difficult intubation score (IDS): scale from 0 (easy) to >5 (very difficult)

  7. Intubation difficulties with Cormack-Lehane classification

    Time frame: Baseline

    Intubation difficulties Measured by Cormack-Lehane classification (from 1: easy to 4 difficult)

  8. Percentage of use of the study's emergency

    Time frame: Baseline

    Intubation difficulties measured by percentage of use of the study's emergency

  9. Traumatic complications: anatomical lesion

    Time frame: Baseline

    Percentage of patients with an anatomical lesion (dental fracture, lip or mouth wound, oropharyngeal haemorrhage, vocal cord trauma)

  10. Traumatic complications: postoperative functional discomfort

    Time frame: Day 2

    Percentage of patients with postoperative functional discomfort (laryngeal pain, aphonia or dysphonia).

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients with Two Doses of Remifentanil: a Pilot Study

Acronym: OBEREM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Feb 18, 2025

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.

Published trials that share one or more normalized conditions with this study.