Efficacy and Safety Study of Two Propofol Formulations

B. Braun

Status and phase

Completed

Phase 3

Conditions

Induction of Anaesthesia

General Anaesthesia

Treatments

Drug: Propofol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00506246

2006L00667

Details and patient eligibility

About

The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia

Full description

Propofol (chemical substance 2, 6-Diisopropylphenol) is a short-acting intravenous general anaesthetic which is used for induction and maintenance of a general anaesthesia, for long-term sedation of ventilated intensive care patients or for short-term sedation in diagnostic and surgical procedures. As an active substance propofol produces good and readily controlled anaesthesia with smooth and problem-free recovery both in adult patients and in children over 1 month of age. One potential advantage of this formulation is that the MCT/LCT-emulsion reduces pain on injection, a frequently reported adverse reaction with LCT-emulsions of propofol.

Enrollment

220 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Female and male adult patients, and at least 18 and maximal 65 years of age;
ASA-classification I to II;
Undergoing an elective surgery, the anaesthesia is expected to last at least 1 hour and no more than 3 hours;
Will be under total intravenous anaesthesia;
Willing to give their signed informed consent.