Use of a Modified Propofol Emulsion in Adults

Study Overview
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Brief Summary
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The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia. Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.

Detailed Description
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Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.

Official Title
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Prospective, Monocentric Controlled, Randomized, Double-blind Study to Compare the Two Different Propofol Emulsions Regarding Tolerability and Injection Pain During the Induction of Anesthesia in Adults

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Propofol
* Drug: Propofol 1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults, age ≥ 18 years and ≤ 80 years Anesthetic risk classified as ASA I-III Patients undergoing elective surgery under general anesthesia Signed informed consent Exclusion Criteria: Simultaneous participation in another trial Known or suspected drug abuse Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics) Patients taking lipid lowering drugs History of decompensated renal failure History of severe hepatic dysfunction, hepatic cirrhosis Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia History of convulsive disorders Decompensated cardiac insufficiency Hypovolemia Increased intracranial pressure Pregnancy (positive ß-HCG test) and lactation Emergency situation Patient who receives parenteral fat emulsion, e.g. intralipid Patients incapable of giving consent personally Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Modified propofol (Propofol 0.5%) | Drug: Propofol<br>* Propofol (drug), intravenous, induction of anesthesia<br>* Other names: Modified propofol;|
| Active Comparator: 2<br>Propofol 1% | Drug: Propofol 1%<br>* Propofol (drug), intravenous, induction of anesthesia<br>* Other names: Propofol-Lipuro 1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Expression of Pain During Injection |  | during first propofol bolus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further Assessment of Injection Pain |  | during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Induction, Pain