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

NCT ID: NCT05026125

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-13
• Study Completion Date: 2023-08-11

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.

Conditions

Obesity; Bariatric Surgery Candidate; Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group control

3 μg/kg (Ideal Body Weight) of Remifentanil

Group Type: ACTIVE_COMPARATOR

Remifentanil Injection

Intervention Type: DRUG

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

Group Active

3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil

Group Type: EXPERIMENTAL

Remifentanil Injection plus 30%

Intervention Type: 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

Interventions

Remifentanil Injection

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

Intervention Type: DRUG

Remifentanil Injection plus 30%

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

Intervention Type: DRUG

Other Intervention Names

orotracheal intubation; anesthesia; bariatric surgery; orotracheal intubation; anesthesia; bariatric surgery

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Géraldine FAURE, Md

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Hospital University of Toulouse

Toulouse, , France

Countries

France

Other Identifiers

2021-000727-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RC31/20/0443

Identifier Type: -

Identifier Source: org_study_id