TerminatedNCT00779844LoopObeseUpdated Sep 23, 2016

Anesthesic Propofol and Remifentanil Requirements in Obese Patients

A Phase 4 interventional study of bariatric coelioscopic surgical procedure and supra-umbilical coelioscopic surgical procedure in Anesthesia and Obesity, sponsored by Hopital Foch. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by Hopital Foch · Phase 4, Interventional, and Treatment

Why this study was terminated

difficulty in recruiting

Phase: Phase 4
Study type: Interventional
Enrollment: 63
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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

Conditions studied

Anesthesia
Obesity

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Obesity 6,296

Keywords

Anesthesia
Obesity

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 63 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
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

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)

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 63 participants (actual)

Study arms

Experimental
1
obese patients
Procedure: bariatric coelioscopic surgical procedure
Active comparator
2
lean patients
Procedure: supra-umbilical coelioscopic surgical procedure

Interventions

Procedurebariatric 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
Proceduresupra-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

What researchers measure

Primary outcomes

Dose of propofol administered
Time frame: intraoperatively

Secondary outcomes

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

Study locations

1 site

Hôpital Européen Georges Pompidou
Paris, 75015, France

References and documents

Publications

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. PubMed 16571963 ↗
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. PubMed 8466066 ↗
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. PubMed 25500680 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00779844
Lead sponsor: Hopital Foch
Responsible party: Sponsor
First posted: Oct 24, 2008
Start date: Dec 2008
Primary completion: Dec 2012
Completion: Dec 2012
Last update: Sep 23, 2016

Study contacts

Marc Fischler, MD

study chair · Hopital Foch

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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