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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Bariatric Surgery Candidate, Intubation Complication

Intervention / Treatment
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* Drug: Remifentanil Injection
* Drug: Remifentanil Injection plus 30%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, double blinded and monocentric Pilot Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group control<br>3 μg/kg (Ideal Body Weight) of Remifentanil | Drug: Remifentanil Injection<br>* Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery<br>* Other names: bariatric surgery;|
| Experimental: Group Active<br>3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil | Drug: Remifentanil Injection plus 30%<br>* Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery<br>* Other names: bariatric surgery;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal intubation, obese patient, neuromuscular blocking agent, remifentanil