Use of a Modified Propofol Emulsion in Adults

NCT ID: NCT00690495

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-09-30

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Modified propofol (Propofol 0.5%)

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Propofol (drug), intravenous, induction of anesthesia

2

Propofol 1%

Group Type: ACTIVE_COMPARATOR

Propofol 1%

Intervention Type: DRUG

Propofol (drug), intravenous, induction of anesthesia

Interventions

Propofol

Propofol (drug), intravenous, induction of anesthesia

Intervention Type: DRUG

Propofol 1%

Propofol (drug), intravenous, induction of anesthesia

Intervention Type: DRUG

Other Intervention Names

Modified propofol; Propofol-Lipuro 1%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Soltész, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

Locations

Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

Leverkusen, North Rhine-Westphalia, Germany

Countries

Germany

References

Soltesz S, Diekmann M, Mitrenga-Theusinger A, Keilen M, Molter GP. Reduced pain on injection with a 0.5% propofol emulsion during induction of anesthesia. Eur J Anaesthesiol. 2012 Mar;29(3):162-3. doi: 10.1097/EJA.0b013e32834cfa7d. No abstract available.

Reference Type: DERIVED

PMID: 22012178 (View on PubMed)

Other Identifiers

HC-G-H-0705

Identifier Type: -

Identifier Source: org_study_id