NCT05026125

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2022-01-13
• Primary completion: 2023-08-11
• Completion: 2023-08-11
• First posted: 2021-08-30
• Last updated: 2025-02-18

Locations

1 site across 1 country: France