Anesthesic Propofol and Remifentanil Requirements in Obese Patients (LoopObese)

This study has been terminated.
(difficulty in recruiting)
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: October 23, 2008
Last updated: September 10, 2013
Last verified: September 2013
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

Condition Intervention Phase
Procedure: bariatric coelioscopic surgical procedure
Procedure: supra-umbilical coelioscopic surgical procedure
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements

Resource links provided by NLM:

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Dose of propofol administered [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: December 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
obese patients
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
Active Comparator: 2
lean patients
Procedure: 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00779844

Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Hopital Foch
Study Chair: Marc Fischler, MD Hopital Foch
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hopital Foch Identifier: NCT00779844     History of Changes
Other Study ID Numbers: 2008/02 
Study First Received: October 23, 2008
Last Updated: September 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:

Additional relevant MeSH terms:
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Hypnotics and Sedatives
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016