Anesthesic Propofol and Remifentanil Requirements in Obese Patients

Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00779844

Acronym

LoopObese

Enrollment

Registered

2008-10-24

Start date

2008-12-31

Completion date

2012-12-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Obesity

Keywords

Anesthesia, Obesity

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

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Dose of propofol administered	intraoperatively

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026