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Anesthesic Propofol and Remifentanil Requirements in Obese Patients (LoopObese)

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ClinicalTrials.gov Identifier: NCT00779844
Recruitment Status : Terminated (difficulty in recruiting)
First Posted : October 24, 2008
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Anesthesia Obesity Procedure: bariatric coelioscopic surgical procedure Procedure: supra-umbilical coelioscopic surgical procedure Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements
Study Start Date : December 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Dose of propofol administered [ Time Frame: intraoperatively ]

Secondary Outcome Measures :
  1. remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver [ Time Frame: intraoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779844


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00779844     History of Changes
Other Study ID Numbers: 2008/02
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Hopital Foch:
Anesthesia
Obesity

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents