Anesthesic Propofol and Remifentanil Requirements in Obese Patients

NCT00779844 | Terminated Phase 4

• 1 other identifier: 2008/02
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia; Obesity

Keywords

Anesthesia; Obesity

Outcome Measures

Primary Outcomes (1)

• Dose of propofol administered

  intraoperatively

Secondary Outcomes (1)

• remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver

  intraoperatively

Study Arms (2)

1

EXPERIMENTAL

obese patients

Procedure: bariatric coelioscopic surgical procedure

2

ACTIVE COMPARATOR

lean patients

Procedure: supra-umbilical coelioscopic surgical procedure

Interventions

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

1

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) or for an upper abdominal laparoscopic procedure (lean patients)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (3)

• 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.

  PMID: 16571963 BACKGROUND

• 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.

  PMID: 8466066 BACKGROUND

• 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.

  PMID: 25500680 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Fischler, MD

  Hopital Foch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)