Use of a Modified Propofol Emulsion in Adults

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG
• Treatments: Anesthetics; Propofol

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

• 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