Relation dose-effet du propofol : comparaison en double aveugle des différentes - Les Propofols

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

• Registration Number: EUCTR2009-012898-36-FR
• Lead Sponsor: Hopital Foch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Ptients 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, breastfeeding woman
Allergy to propofol, soybeans or peanuts
Allergy to lidocaïne,
History of central neurological disorder or brain injury
Patient with pacemaker
Patient receiving psychotropic drugs

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective is to compare propofol doses required to acheive anesthetic induction. Each group of patients will receive one of the 4 different pharmaceutical formula plain or with lidocaine<br><br>;Secondary Objective: Secondary objectives are<br>- evaluation of pain during injection,<br>- hemodynamic consequence of anesthetic induction,<br>- comparison of measured and calculated plasma concentrations of propofol.;Primary end point(s): Comparaison of propofol doses between the 6 groups of patients