Evaluation de l’effet anesthésique du protoxyde d’azote dans une population d’opérés recevant une anesthésie totale intraveineuse en « boucle » guidée par l’index bispectral (Effect of nitrous oxide on intra-venous closed-loop anesthesia) - Drone-Proto
Phase 1
- Conditions
- general anesthesiaMedDRA version: 9.1Level: LLTClassification code 10002323Term: Anesthesia general
- Registration Number
- EUCTR2007-001677-28-BE
- Lead Sponsor
- Hopital Foch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 560
Inclusion Criteria
general anaesthesia with controlled ventilation
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,
- allergy to the propofol or to a muscle myorelaxant,
- patients receiving a psychotropic treatment,
- presence of a central neurological disorder or a lesion cerebral,
- patients having an anomaly of blood cells count preoperative biological assessment),
- patients having had an anaesthesia in the previous month.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the study is to analyze the influence of nitrous oxide on the automated administration of propofol and remifentanil.;Secondary Objective: The secondary objectives relate to the consequences of the use of nitrous oxide on the performance of the automated administration system and on the time of extubation.;Primary end point(s): The primary endpoint is the posology of propofol administered during the phase of maintenance of the anaesthesia.
- Secondary Outcome Measures
Name Time Method