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

Phase 4

Completed

• Conditions: Intubation Complication; Obesity; Bariatric Surgery Candidate
• Interventions: Drug: Remifentanil Injection plus 30%; Drug: Remifentanil Injection

• Registration Number: NCT05026125
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-30
• Study Start: 2022-01-13
• Primary Completion: 2023-08-11
• Study Completion: 2023-08-11
• Status Verified: 2023-10
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Active	Remifentanil Injection plus 30%	3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil
Group control	Remifentanil Injection	3 μg/kg (Ideal Body Weight) of Remifentanil

Primary Outcome Measures

Name	Time	Method
percentage of patients with excellent conditions of intubation	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 Outcome Measures

Name	Time	Method
Percentage of use of the study's emergency	Baseline	Intubation difficulties measured by percentage of use of the study's emergency
Intubation difficulties with Cormack-Lehane classification	Baseline	Intubation difficulties Measured by Cormack-Lehane classification (from 1: easy to 4 difficult)
Respiratory effects: patients with aspiration	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).
Hemodynamic effects : hypotension	Baseline	Percentage of patients with arterial hypotension (\>20% decrease in mean arterial pressure) within 40 minutes of intubation
Hemodynamic effects: bradycardia	Baseline	Percentage of patients with bradycardia (\>20% decrease in heart rate) within 40 minutes after intubation
Hemodynamic effects: use of vasopressor drugs	Baseline	Number of times vasopressor drugs were used.after intubation
Respiratory effects: patients with desaturation day 0	Baseline	Percentage of patients with desaturation (pulse oximetry (SpO2) below 90%.)
Intubation complexity	Baseline	Intubation complexity Measured by Difficult intubation score (IDS): scale from 0 (easy) to \>5 (very difficult)
Traumatic complications: anatomical lesion	Baseline	Percentage of patients with an anatomical lesion (dental fracture, lip or mouth wound, oropharyngeal haemorrhage, vocal cord trauma)
Traumatic complications: postoperative functional discomfort	Day 2	Percentage of patients with postoperative functional discomfort (laryngeal pain, aphonia or dysphonia).

Trial Locations

Locations (1)

Hospital University of Toulouse; 🇫🇷 Toulouse, France