Back to resultsAnesthesic Propofol and Remifentanil Requirements in Obese Patients (LoopObese)
Primary Purpose
Anesthesia, Obesity
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
bariatric coelioscopic surgical procedure
supra-umbilical coelioscopic surgical procedure
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia focused on measuring Anesthesia, Obesity
Eligibility 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)
Sites / Locations
- Hôpital Européen Georges Pompidou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
obese patients
lean patients
Outcomes
Primary Outcome Measures
Dose of propofol administered
Secondary Outcome Measures
remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00779844
Brief Title
Anesthesic Propofol and Remifentanil Requirements in Obese Patients
Acronym
LoopObese
Official Title
Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
difficulty in recruiting
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Obesity
Keywords
Anesthesia, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
obese patients
Arm Title
2
Arm Type
Active Comparator
Arm Description
lean patients
Intervention Type
Procedure
Intervention Name(s)
bariatric coelioscopic surgical procedure
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
supra-umbilical coelioscopic surgical procedure
Intervention Description
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 Measure Information:
Title
Dose of propofol administered
Time Frame
intraoperatively
Secondary Outcome Measure Information:
Title
remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver
Time Frame
intraoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fischler, MD
Organizational Affiliation
Hopital Foch
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
16571963
Citation
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.
Results Reference
background
PubMed Identifier
8466066
Citation
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.
Results Reference
background
PubMed Identifier
25500680
Citation
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.
Results Reference
derived
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Anesthesic Propofol and Remifentanil Requirements in Obese Patients
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