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

Obesity Clinical Trial

— OBEREM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05026125
• Other study ID #: RC31/20/0443
• Secondary ID: 2021-000727-12
• Status: Completed
• Phase: Phase 4
• Start date: January 13, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Intubation Complication
• Obesity

Intervention

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
• 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

Locations

Country	Name	City	State
France	Hospital University of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hemodynamic events day 0	Incidence rate of haemodynamic events at day 0	Day 0
Secondary	Hemodynamic events day 3	Incidence rate of haemodynamic events at day 3	Day 3
Secondary	Respiratory events day 0	Incidence rate of respiratory events at day 0	day 0
Secondary	Respiratory events day 3	Incidence rate of respiratory events at day 3	day 3