Anesthesic Propofol and Remifentanil Requirements in Obese Patients

Obesity Clinical Trial

— LoopObese  

Official title:

Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00779844
• Other study ID #: 2008/02
• Status: Terminated
• Phase: Phase 4
• First received: October 23, 2008
• Last updated: September 22, 2016
• Start date: December 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Obesity

Intervention

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
• 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

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of propofol administered		intraoperatively	No
Secondary	remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver		intraoperatively	No