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OpenTrials
Completed

NCT Number: NCT00690495

Use of a Modified Propofol Emulsion in Adults

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

Leverkusen, North Rhine-Westphalia, 51375, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Propofol (drug), intravenous, induction of anesthesia

Other names: Modified propofol

Propofol 1%

Drug

Propofol (drug), intravenous, induction of anesthesia

Other names: Propofol-Lipuro 1%

Primary outcomes

  1. Incidence of Expression of Pain During Injection

    Time frame: during first propofol bolus

Secondary outcomes

  1. Further Assessment of Injection Pain

    Time frame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2008
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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