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Use of a Modified Propofol Emulsion in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00690495
First received: June 2, 2008
Last updated: January 2, 2012
Last verified: January 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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
Experimental: 1
Modified propofol (Propofol 0.5%)
 Drug: Propofol
Propofol (drug), intravenous, induction of anesthesia
Other Name: Modified propofol
Active Comparator: 2
Propofol 1%
 Drug: Propofol 1%
Propofol (drug), intravenous, induction of anesthesia
Other Name: Propofol-Lipuro 1%

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
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 by B. Braun Melsungen AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00690495     History of Changes
Other Study ID Numbers: HC-G-H-0705
Study First Received: June 2, 2008
Results First Received: August 17, 2011
Last Updated: January 2, 2012
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 May 23, 2013