Etude pilote des signes électro-encéphalographiques de réveil secondaire à l’injection de sugammadex : évaluation par l’enregistrement de l’Index Bispectral et du NeuroSENSE (étude prospective, randomisée, monocentrique et réalisée en double aveugle) - Suggamadex-Réveil

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

• Registration Number: EUCTR2010-018303-28-FR
• Lead Sponsor: Hopital Foch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients scheduled for general anesthesia
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 under 18 years
- Pregnancy, non menopausal woman
- Allergy to propofol, soybeans or peanuts
- Allergy to sufentanil, remifentanil, morphine, or to a component
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl
- Allergy to rocuronium or to bromure ion
- History of a central neurological disorder or of a lesion cerebral
- Patients receiving a psychotropic treatment
- Presence of a pace-maker
- Hypersensibility to sugammadex or to a component
- Preoperative or immediate postoperative treatment with toremifene, flucloxacilline, or fusidic acid

Study & Design

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