Obesity, Bariatric Surgery Candidate, Intubation Complication
Conditions
Keywords
tracheal intubation, obese patient, neuromuscular blocking agent, remifentanil
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.
Interventions
Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
DRUGRemifentanil 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
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
with randomization envelopes opened by the care provider
Intervention model description
Prospective, randomized, controlled, double blinded and monocentric Pilot Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients with excellent conditions of intubation | Baseline | Intubation conditions will be assessed using the intubation conditions score proposed by Viby-Mogensen and al. (Scandinavian score). The score defines intubation conditions: excellent (all variables are excellent), good (all variables are either excellent or good), or poor (presence of a poor variable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation complexity | Baseline | Intubation complexity Measured by Difficult intubation score (IDS): scale from 0 (easy) to \>5 (very difficult) |
| Hemodynamic effects : hypotension | Baseline | Percentage of patients with arterial hypotension (\>20% decrease in mean arterial pressure) within 40 minutes of intubation |
| Hemodynamic effects: bradycardia | Baseline | Percentage of patients with bradycardia (\>20% decrease in heart rate) within 40 minutes after intubation |
| Hemodynamic effects: use of vasopressor drugs | Baseline | Number of times vasopressor drugs were used.after intubation |
| Respiratory effects: patients with aspiration | From Baseline to day 2 | Percentage of patients with aspiration (defined by the existence of gastric fluid in the oropharynx during direct laryngoscopy or by the diagnosis of pneumopathy within 48 hours of surgery). |
| Intubation difficulties with Cormack-Lehane classification | Baseline | Intubation difficulties Measured by Cormack-Lehane classification (from 1: easy to 4 difficult) |
| Percentage of use of the study's emergency | Baseline | Intubation difficulties measured by percentage of use of the study's emergency |
| Traumatic complications: anatomical lesion | Baseline | Percentage of patients with an anatomical lesion (dental fracture, lip or mouth wound, oropharyngeal haemorrhage, vocal cord trauma) |
| Traumatic complications: postoperative functional discomfort | Day 2 | Percentage of patients with postoperative functional discomfort (laryngeal pain, aphonia or dysphonia). |
| Respiratory effects: patients with desaturation day 0 | Baseline | Percentage of patients with desaturation (pulse oximetry (SpO2) below 90%.) |
Countries
France
Outcome results
None listed