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
Overview
- Phase
- Phase 3
- Intervention
- Propofol
- Conditions
- Anesthesia
- Sponsor
- B. Braun Melsungen AG
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of Expression of Pain During Injection
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Modified propofol (Propofol 0.5%)
Intervention: Propofol
2
Propofol 1%
Intervention: Propofol 1%
Outcomes
Primary Outcomes
Incidence of Expression of Pain During Injection
Time Frame: during first propofol bolus
Secondary Outcomes
- Further Assessment of Injection Pain(during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia)