EUCTR2021-000727-12-FR
Active, not recruiting
Phase 1
Quality Assessment of Tracheal intubation without neuromuscular blocking drugs (Propofol+ Remifentanil) in obese patients: Pilot Study - OBEREM
niversity Hospital of Toulouse0 sites60 target enrollmentMay 11, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital of Toulouse
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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