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difficulty in recruiting
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | obese patients |
|
| 2 | Active Comparator | lean patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bariatric coelioscopic surgical procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose of propofol administered | intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver | intraoperatively |
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Inclusion Criteria:
- Patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) or for an upper abdominal laparoscopic procedure (lean patients)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hopital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16571963 | Background | Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe 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. doi: 10.1097/00000542-200604000-00012. | |
| 8466066 |
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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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| supra-umbilical coelioscopic surgical procedure | 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 |
|
| 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. doi: 10.1097/00000542-199304000-00008. |
| 25500680 | Derived | Liu N, Lory C, Assenzo V, Cocard V, Chazot T, Le Guen M, Sessler DI, Journois D, Fischler M. Feasibility of closed-loop co-administration of propofol and remifentanil guided by the bispectral index in obese patients: a prospective cohort comparison. Br J Anaesth. 2015 Apr;114(4):605-14. doi: 10.1093/bja/aeu401. Epub 2014 Dec 10. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |