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Use of a Modified Propofol Emulsion in Adults

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ClinicalTrials.gov Identifier: NCT00690495
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : September 22, 2011
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anesthesia Drug: Propofol Drug: Propofol 1% Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Expression of Pain During Injection [ Time Frame: during first propofol bolus ]

Secondary Outcome Measures :
  1. Further Assessment of Injection Pain [ Time Frame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690495


Locations
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Germany
Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
Leverkusen, Nordrhein-Westfalen, Germany, 51375
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
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Principal Investigator: Stefan Soltész, MD, PhD Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00690495    
Other Study ID Numbers: HC-G-H-0705
First Posted: June 4, 2008    Key Record Dates
Results First Posted: September 22, 2011
Last Update Posted: January 5, 2012
Last Verified: January 2012
Keywords provided by B. Braun Melsungen AG:
Anesthesia
Induction
Pain
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics