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Prospective, monocentric, controlled, randomized, double-blind study to compare two different propofol emulsions regarding tolerability and injection pain during the induction of anesthesia in adults

Prospective, monocentric, controlled, randomized, double-blind study to compare two different propofol emulsions regarding tolerability and injection pain during the induction of anesthesia in adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003571-39-DE
Enrollment
Unknown
Registered
2008-05-20
Start date
2008-04-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

reduction of injection pain during induction of anaesthesia

Interventions

Product Name: Propofol 0.5% Product Code: Propofol 0.5% Pharmaceutical Form: Emulsion for injection INN or Proposed INN: Propofol CAS Number: 2078-54-8 Other descriptive name: 2.6-Di-isopropylphenol
2.6-bis(1-methylethyl)phenol
Disoprofol
Propofolum Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Trade Name: Propofol-Lipuro 1% Product Name: Propofol-Lipuro 1% Product Code: Propofol
Propofolum Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-

Sponsors

B. Braun Melsungen AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Male and female adults, age = 18 years and = 80 years Anaesthetic risk classified as ASA I-III Patients undergoing elective surgery under general anesthesia Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 acitive analgesics) Patients taking lipid lowering drugs History of severe hepatic dysfunction, hepatic cirrhosis History of decompensated renal failure 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 Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal Emergency situation Patient who receives parenteral fat emulsion, e.g. intralipid Patients incapable of giving consent personally

Design outcomes

Primary

MeasureTime frame
Main Objective: tolerability and injection pain;Secondary Objective: efficacy and safety;Primary end point(s): Incidence of spontaneous expressions of pain during injection—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026