Efficacy and Safety Study of Two Propofol Formulations

Study Overview
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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

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.

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

Conditions
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General Anaesthesia, Induction of Anaesthesia

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Propofol MCT/LCT | Drug: Propofol<br>* intravenous (total intravenous anaesthesia) induction and maintenance<br>* Other names: Diprivan 1%;|
| Active Comparator: 2<br>Propofol LCT | Drug: Propofol<br>* intravenous (total intravenous anaesthesia) induction and maintenance<br>* Other names: Diprivan 1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaesthesia