Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
Leverkusen, North Rhine-Westphalia, 51375, Germany
NCT Number: NCT00690495
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Leverkusen, North Rhine-Westphalia, 51375, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Propofol (drug), intravenous, induction of anesthesia
Other names: Modified propofol
Propofol (drug), intravenous, induction of anesthesia
Other names: Propofol-Lipuro 1%
Time frame: during first propofol bolus
Time frame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia
B. Braun Melsungen AG
Industry
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
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