Efficacy and Safety Study of Two Propofol Formulations

B. Braun Melsungen AG220 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

General Anaesthesia Induction of Anaesthesia

Interventions

PropofolDRUG

* intravenous (total intravenous anaesthesia) * induction and maintenance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (3)

Pekin Union Medical College Hospital

Beijing, China

Renji Hospital Affiliated to Shanghai Jiaotong University

Shanghai, China

Zhongshan Hospital affiliated to Fudan University

Shanghai, China

Outcomes

Primary Outcomes

time to loss of eyelash reflex

Time frame: induction of anaesthesia

doses required for induction of anaesthesia until loss of eyelash reflex

Time frame: induction of anaesthesia