Use of a Modified Propofol Emulsion in Adults

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690495
• Other study ID #: HC-G-H-0705
• Status: Completed
• Phase: Phase 3
• First received: June 2, 2008
• Last updated: January 2, 2012
• Start date: May 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2012
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol
Propofol (drug), intravenous, induction of anesthesia
• Propofol 1%
Propofol (drug), intravenous, induction of anesthesia

Locations

Country	Name	City	State
Germany	Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH	Leverkusen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Expression of Pain During Injection		during first propofol bolus	Yes
Secondary	Further Assessment of Injection Pain		during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia	Yes