Use of a Modified Propofol Emulsion in Adults - Full Text View

Sponsor:	B. Braun Melsungen AG
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00690495

Purpose

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.

Condition	Intervention	Phase
Anesthesia	Drug: Propofol Drug: Propofol 1%	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol

U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:

incidence of expression of pain during injection [ Time Frame: during first propofol bolus ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

further assessment of injection pain [ Time Frame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	May 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Modified propofol	Drug: Propofol Propofol (drug), intravenous, induction of anesthesia
2: Active Comparator Propofol 1%	Drug: Propofol 1% Propofol (drug), intravenous, induction of anesthesia

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690495

Locations

Germany, Nordrhein-Westfalen
Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
Leverkusen, Nordrhein-Westfalen, Germany, 51375

Sponsors and Collaborators

B. Braun Melsungen AG

Investigators

Principal Investigator:

Stefan Soltész, MD, PhD

Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

More Information

No publications provided

Responsible Party:	B. Braun Melsungen AG ( Tamara Dehnhardt )
ClinicalTrials.gov Identifier:	NCT00690495 History of Changes
Other Study ID Numbers:	HC-G-H-0705
Study First Received:	June 2, 2008
Last Updated:	April 14, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by B. Braun Melsungen AG:

Anesthesia
Induction
Pain

Additional relevant MeSH terms:

Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on September 07, 2010