Use of a Modified Propofol Emulsion in Adults

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: Propofol 1%; Drug: Propofol

• Registration Number: NCT00690495
• Lead Sponsor: B. Braun Melsungen AG

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2011-08-17
• Results First Posted: 2011-09-22
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-02
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Propofol 1%	Propofol 1%
1	Propofol	Modified propofol (Propofol 0.5%)

Primary Outcome Measures

Name	Time	Method
Incidence of Expression of Pain During Injection	during first propofol bolus

Secondary Outcome Measures

Name	Time	Method
Further Assessment of Injection Pain	during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia

Trial Locations

Locations (1)

Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH; 🇩🇪 Leverkusen, Nordrhein-Westfalen, Germany