Efficacy and Safety Study of Two Propofol Formulations

A Multi-Center, Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy and Safety of Propofol(Propofol®-Lipuro) in Total Intravenous Anaesthesia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00506246

Enrollment

220

Registered

2007-07-25

Start date

2007-06-30

Completion date

2007-10-31

Last updated

2008-02-25

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

Conditions

General Anaesthesia, Induction of Anaesthesia

Keywords

anaesthesia

Brief summary

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

Detailed 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.

Interventions

DRUGPropofol

* intravenous (total intravenous anaesthesia) * induction and maintenance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
time to loss of eyelash reflex	induction of anaesthesia
doses required for induction of anaesthesia until loss of eyelash reflex	induction of anaesthesia

Secondary

Measure	Time frame
anaesthesia relating data	during anaesthesia
recovery data	during anaesthesia
patient data/history	during anaesthesia
adverse events	during anaesthesia
drug safety data (e.g. haemodynamics and clinical outcome)	during anaesthesia
pre- and concomitant medication	during anaesthesia

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026