LoopObese: Anesthesic Propofol and Remifentanil Requirements in Obese Patients
Study Details
Study Description
Brief Summary
Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is to compare the propofol and remifentanil doses required to maintain the bispectral index in the range 40-60 in two groups of patients: obese patients and lean patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 obese patients |
Procedure: bariatric coelioscopic surgical procedure
total intra-venous anesthesia (propofol and remifentanil) being delivered using a close-loop system with the Bispectral Index as the single input for the controller
|
| Active Comparator: 2 lean patients |
Procedure: supra-umbilical coelioscopic surgical procedure
total intra-venous anesthesia (propofol and remifentanil) being delivered using a closed-loop system with the Bispectral Index as the single input for the controller
|
Outcome Measures
Primary Outcome Measures
- Dose of propofol administered [intraoperatively]
Secondary Outcome Measures
- remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver [intraoperatively]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) or for an upper abdominal laparoscopic procedure (lean patients)
Exclusion Criteria:
-
age lower than 18 years,
-
pregnant woman,
-
presence of a central neurological disorder or a lesion cerebral, of a severe respiratory or hepatic insufficiency,
-
allergy to propofol, or to soja or to peanuts, or to sufentanil, or to remifentanil, or to morphine, or to a muscle myorelaxant, or to an excipient,
-
hypersensibility to sufentanil, or to remifentanil or to another derivate of fentanyl,
-
allergy to latex,
-
presence of a symptomatic gastroesophageal reflux,
-
patients receiving a psychotropic treatment or a agonist-antagonist opiate,
-
presence of predictive signs of difficult mask ventilation of difficult intubation (else than obesity)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Européen Georges Pompidou | Paris | France | 75015 |
Sponsors and Collaborators
- Hopital Foch
Investigators
- Study Chair: Marc Fischler, MD, Hopital Foch
Study Documents (Full-Text)
None provided.More Information
Publications
- Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.
- Servin F, Farinotti R, Haberer JP, Desmonts JM. Propofol infusion for maintenance of anesthesia in morbidly obese patients receiving nitrous oxide. A clinical and pharmacokinetic study. Anesthesiology. 1993 Apr;78(4):657-65.
- 2008/02