Phase 3 N=100 Randomized Double-blind Prevention

Use of a Modified Propofol Emulsion in Adults

Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT00690495 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Sep 2011

Primary outcome: Primary: Incidence of Expression of Pain During Injection — 1; 7 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Propofol (Drug); Propofol 1% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: B. Braun Melsungen AG
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Expression of Pain During Injection	1; 7	—
SECONDARY Further Assessment of Injection Pain	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00690495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.