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Anesthesic Propofol and Remifentanil Requirements in Obese Patients (LoopObese)

H

Hopital Foch

Status and phase

Terminated
Phase 4

Conditions

Obesity
Anesthesia

Treatments

Procedure: supra-umbilical coelioscopic surgical procedure
Procedure: bariatric coelioscopic surgical procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT00779844
2008/02

Details and patient eligibility

About

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

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

1
Experimental group
Description:
obese patients
Treatment:
Procedure: bariatric coelioscopic surgical procedure
2
Active Comparator group
Description:
lean patients
Treatment:
Procedure: supra-umbilical coelioscopic surgical procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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