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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012898-36-FR

Enrollment

210

Registered

2009-07-17

Start date

2009-09-21

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

general anesthesia MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;Secondary Objective: Secondary objectives are - evaluation of pain during injection, - hemodynamic consequence of anesthetic induction, - comparison of measured and calculated plasma concentrations of propofol.;Primary end point(s): Comparaison of propofol doses between the 6 groups of patients	—

Measure

Time frame

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 ;Secondary Objective: Secondary objectives are - evaluation of pain during injection, - hemodynamic consequence of anesthetic induction, - comparison of measured and calculated plasma concentrations of propofol.;Primary end point(s): Comparaison of propofol doses between the 6 groups of patients

—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026