Clinical trial NCT00779844: Anesthesic Propofol and Remifentanil Requirements in Obese Patients
Official title: Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Obesity
Keywords: Anesthesia
Obesity
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Dose of propofol administered
timeFrame: intraoperatively
Secondary outcomes:
measure: remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.