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Clinical Trials/EUCTR2021-000727-12-FR
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.

Registry
who.int
Start Date
May 11, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospital of Toulouse

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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