Prospective, monocentric, controlled, randomized, double-blind study to comparetwo different propofol emulsions regarding tolerability and injection pain during the induction of anesthesia in adults

• Conditions: reduction of injection pain during induction of anaesthesia

• Registration Number: EUCTR2007-003571-39-DE
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and female adults, age = 18 years and = 80 years
Anaesthetic risk classified as ASA I-III
Patients undergoing elective surgery under general anesthesia
Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 acitive analgesics)
Patients taking lipid lowering drugs
History of severe hepatic dysfunction, hepatic cirrhosis
History of decompensated renal failure
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
Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal
Emergency situation
Patient who receives parenteral fat emulsion, e.g. intralipid
Patients incapable of giving consent personally

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: tolerability and injection pain;Secondary Objective: efficacy and safety;Primary end point(s): Incidence of spontaneous expressions of pain during injection