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

Toulouse University Hospital

Status and phase: Completed; Phase 4

Conditions: Bariatric Surgery Candidate; Obesity; Intubation Complication

Treatments: Drug: Remifentanil Injection plus 30%; Drug: Remifentanil Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05026125

2021-000727-12 (EudraCT Number)

RC31/20/0443

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group control

Active Comparator group

Description:

3 μg/kg (Ideal Body Weight) of Remifentanil

Treatment:

Drug: Remifentanil Injection

Group Active

Experimental group

Description:

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

Treatment:

Drug: Remifentanil Injection plus 30%