Use of a Modified Propofol Emulsion in Adults

B. Braun

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: Propofol 1%; Drug: Propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690495

HC-G-H-0705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Experimental group

Description:

Modified propofol (Propofol 0.5%)

Treatment:

Drug: Propofol

2

Active Comparator group

Description:

Propofol 1%

Treatment:

Drug: Propofol 1%