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

• Registration Number: EUCTR2007-001677-28-FR
• Lead Sponsor: Hopital Foch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-23
• Last Update Posted: 8 August 2022

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.