Quality Assessment of Tracheal intubation without neuromuscular blocking drugs (Propofol+ Remifentanil) in obese patients: Pilot Study

Phase 1

• Conditions: induction phase of the general anesthesia in obese patients; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-000727-12-FR
• Lead Sponsor: niversity Hospital of Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-11
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patient 18-60 years of age.
- ASA class = 3
- Patient with a BMI between 35 and 60 with indication for bariatric surgery, or BMI greater than 30 in case of bariatric surgery revision.
- Patient scheduled for bariatric surgery (or repeat bariatric surgery) scheduled under general anesthesia with orotracheal intubation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Full stomach patient defined by at least 1 of the following criteria:
o Esophageal fibroscopy with visualized hiatal hernia.
o Authenticated and treated gastroesophageal reflux.
o Previously placed gastric band.
- Known difficult orotracheal intubation (Cormack score = 3 (see Appendix 5)31).
- Opioid or substituted drug addiction (Methadone, Buprenorphine...).
- Chronic alcoholism (suspected or admitted).
- Chronic treatment with an opiate.
- Patient under guardianship, curatorship or under court protection.
- Known hypersensitivity to propofol, sufentanil, remifentanil, soy or peanuts.
- Severe renal or hepatic impairment.
- Severe respiratory insufficiency.
- Pregnant or breastfeeding woman.
- Patient participating in another interventional research protocol that may interfere with study drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified