Clinical trial NCT05026125: Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients
Official title: Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients with Two Doses of Remifentanil: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Bariatric Surgery Candidate
Intubation Complication
Keywords: tracheal intubation
obese patient
neuromuscular blocking agent
remifentanil
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, double blinded and monocentric Pilot Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: percentage of patients with excellent conditions of intubation
timeFrame: Baseline
Secondary outcomes:
measure: Hemodynamic effects : hypotension
timeFrame: Baseline
measure: Hemodynamic effects: bradycardia
timeFrame: Baseline
measure: Hemodynamic effects: use of vasopressor drugs
timeFrame: Baseline
measure: Respiratory effects: patients with desaturation day 0
timeFrame: Baseline
measure: Respiratory effects: patients with aspiration
timeFrame: From Baseline to day 2
measure: Intubation complexity
timeFrame: Baseline
measure: Intubation difficulties with Cormack-Lehane classification
timeFrame: Baseline
measure: Percentage of use of the study's emergency
timeFrame: Baseline
measure: Traumatic complications: anatomical lesion
timeFrame: Baseline
measure: Traumatic complications: postoperative functional discomfort
timeFrame: Day 2
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hospital University of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Géraldine FAURE, Md
role: PRINCIPAL_INVESTIGATOR
References: