Status:
COMPLETED
Use of a Modified Propofol Emulsion in Adults
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Anesthesia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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. St...
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. admi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00690495
Start Date
May 1 2008
End Date
September 1 2008
Last Update
January 5 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
Leverkusen, North Rhine-Westphalia, Germany, 51375