Anesthesic Propofol and Remifentanil Requirements in Obese Patients

Phase 4

Terminated

• Conditions: Anesthesia; Obesity
• Interventions: Procedure: bariatric coelioscopic surgical procedure; Procedure: supra-umbilical coelioscopic surgical procedure

• Registration Number: NCT00779844
• Lead Sponsor: Hopital Foch

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Study Start: 2008-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bariatric coelioscopic surgical procedure	obese patients
2	supra-umbilical coelioscopic surgical procedure	lean patients

Primary Outcome Measures

Name	Time	Method
Dose of propofol administered	intraoperatively

Secondary Outcome Measures

Name	Time	Method
remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver	intraoperatively

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France