Efficacy and Safety Study of Two Propofol Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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General Anaesthesia Induction of Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Propofol MCT/LCT

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

* intravenous (total intravenous anaesthesia)
* induction and maintenance

2

Propofol LCT

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

* intravenous (total intravenous anaesthesia)
* induction and maintenance

Interventions

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Propofol

* intravenous (total intravenous anaesthesia)
* induction and maintenance

Intervention Type DRUG

Other Intervention Names

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Propofol Lipuro 1% Diprivan 1%

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No