Anesthésie intraveineuse chez l’obèse : étude des posologies de propofol et de rémifentanil (étude multicentrique, prospective, ouverte comparant un groupe de patients obèses et un groupe de patients de poids normal) - Drone-Obésité

• Conditions: general anaesthesia; MedDRA version: 9.1Level: LLTClassification code 10002323Term: Anesthesia general

• Registration Number: EUCTR2008-000537-22-FR
• Lead Sponsor: Hopital Foch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) ou for a SUS-OBOLICAL coelioscopic surgical procedure (lean patients)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 gastroesophageal reflux or of a hiatal hernia,
- 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified