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Anesthesic Propofol and Remifentanil Requirements in Obese Patients (LoopObese)

This study is currently recruiting participants.
Verified September 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00779844
First received: October 23, 2008
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Anesthesia
Obesity
 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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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 ]

Estimated Enrollment: 70
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779844

Contacts
Contact: Marc Fischler, MD 0033146252442 m.fischler@hopital-foch.org

Locations
France
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Jean Baptiste Dufourcq, MD            
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch
  More Information

Publications:

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00779844     History of Changes
Other Study ID Numbers: 2008/02
Study First Received: October 23, 2008
Last Updated: September 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:
Anesthesia
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013