Clinical trial NCT00690495: Use of a Modified Propofol Emulsion in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: Anesthesia
Induction
Pain
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Incidence of Expression of Pain During Injection
timeFrame: during first propofol bolus
Secondary outcomes:
measure: Further Assessment of Injection Pain
timeFrame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia
Other outcomes:
Locations:
city: Leverkusen
country: Germany
facility: Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
state: Nordrhein-Westfalen
Study officials:
affiliation: Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
name: Stefan Soltész, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soltesz S, Diekmann M, Mitrenga-Theusinger A, Keilen M, Molter GP. Reduced pain on injection with a 0.5% propofol emulsion during induction of anesthesia. Eur J Anaesthesiol. 2012 Mar;29(3):162-3. doi: 10.1097/EJA.0b013e32834cfa7d. No abstract available.