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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: Propofol Frésenius 10 mg/ml Product Name: Propofol Pharmaceutical Form: Intravenous infusion Trade Name: Propofol‐Lipuro Product Name: Propofol Pharmaceutical Form: Intravenous infusion Trade Name: Diprivan 10 mg/ml Product Name: Propofol Pharmaceutical Form: Intravenous infusion Trade Name: Lidocaïne Aguettant 10 mg/ml Product Name: Lidocaine Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: general anesthesia ; MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general PRIMARY OUTCOME: 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; ; Primary end point(s): Comparaison of propofol doses between the 6 groups of patients Secondary Objective: Secondary objectives are; ‐ evaluation of pain during injection,; ‐ hemodynamic consequence of anesthetic induction,; ‐ comparison of measured and calculated plasma concentrations of propofol. 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
Epistemonikos ID: 48fd6bef95fde98070fb150ea0ee0d1038d72280
First added on: Aug 22, 2024