general anesthesia MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general
Conditions
Interventions
Trade Name: Protoxyde d'azote ALS (Nitrous oxide)
Product Name: protoxyde d'azote
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: PROPOFOL
CAS Number: 2078548
Concentration unit: µg/ml microg
Sponsors
Hopital Foch
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium, France, Germany
Outcome results
None listed