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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000727-12 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group control | Active Comparator | 3 μg/kg (Ideal Body Weight) of Remifentanil |
|
| Group Active | Experimental | 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil Injection | Drug | Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with excellent conditions of intubation | 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). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic effects : hypotension | Percentage of patients with arterial hypotension (>20% decrease in mean arterial pressure) within 40 minutes of intubation | Baseline |
| Hemodynamic effects: bradycardia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Géraldine FAURE, Md | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital University of Toulouse | Toulouse | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41207379 | Derived | Goudy P, Denis-Bonnin A, Thalamas C, Rousseau V, Migueres I, Faure G, Minville V. Quality of intubation using remifentanil in obese patients (OBEREM): A randomised, double-blind pilot trial. Anaesth Crit Care Pain Med. 2026 May;45(3):101673. doi: 10.1016/j.accpm.2025.101673. Epub 2025 Nov 7. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D000758 | Anesthesia |
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Prospective, randomized, controlled, double blinded and monocentric Pilot Study
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with randomization envelopes opened by the care provider
|
| Remifentanil Injection plus 30% | Drug | Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery |
|
|
Percentage of patients with bradycardia (>20% decrease in heart rate) within 40 minutes after intubation
| Baseline |
| Hemodynamic effects: use of vasopressor drugs | Number of times vasopressor drugs were used.after intubation | Baseline |
| Respiratory effects: patients with desaturation day 0 | Percentage of patients with desaturation (pulse oximetry (SpO2) below 90%.) | Baseline |
| Respiratory effects: patients with aspiration | 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). | From Baseline to day 2 |
| Intubation complexity | Intubation complexity Measured by Difficult intubation score (IDS): scale from 0 (easy) to >5 (very difficult) | Baseline |
| Intubation difficulties with Cormack-Lehane classification | Intubation difficulties Measured by Cormack-Lehane classification (from 1: easy to 4 difficult) | Baseline |
| Percentage of use of the study's emergency | Intubation difficulties measured by percentage of use of the study's emergency | Baseline |
| Traumatic complications: anatomical lesion | Percentage of patients with an anatomical lesion (dental fracture, lip or mouth wound, oropharyngeal haemorrhage, vocal cord trauma) | Baseline |
| Traumatic complications: postoperative functional discomfort | Percentage of patients with postoperative functional discomfort (laryngeal pain, aphonia or dysphonia). | Day 2 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000760 | Anesthesia and Analgesia |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |