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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate; Intubation Complication
• Intervention / Treatment: Drug: Remifentanil Injection; Drug: Remifentanil Injection plus 30%

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Géraldine FAURE, MD; Phone Number: +33 05 61 32 30 23; Email: faure.geraldine@chu-toulouse.fr
• Study Contact Backup: Name: Pierre GOUDY, MD; Email: goudy.p@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Hospital University of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group control; 3 μg/kg (Ideal Body Weight) of Remifentanil	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; Other Names: anesthesia; orotracheal intubation; bariatric surgery
Experimental: Group Active; 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil	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; Other Names: anesthesia; orotracheal intubation; bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of good to excellent conditions of intubation	percentage of good to excellent conditions of intubation in obese patients using the Intubation Difficulty Scale (IDS). The IDS is graded in the operating theater during the induction of general anesthesia.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic events day 0	Incidence rate of haemodynamic events at day 0	Day 0
Hemodynamic events day 3	Incidence rate of haemodynamic events at day 3	Day 3
Respiratory events day 0	Incidence rate of respiratory events at day 0	day 0
Respiratory events day 3	Incidence rate of respiratory events at day 3	day 3

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Géraldine FAURE, Md, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: remifentanil; neuromuscular blocking agent; obese patient; tracheal intubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Remifentanil
• Other Study ID Numbers: RC31/20/0443; 2021-000727-12 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No