A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Postoperative Nausea and Vomiting (PONV)
- Conditions
- Postoperative Nausea and VomitingMedDRA version: 8.1 Level: LLT Classification code 10036238
- Registration Number
- EUCTR2006-001761-42-LT
- Lead Sponsor
- Merck & Co., Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 700
Patient is at least 18 years of age.
Patient is scheduled to undergo open abdominal surgery or laparoscopically-assisted vaginal hysterectomy requiring overnight hospital stay (24-hour hospital stay after surgery).
Patient is scheduled to receive general anesthesia, including induction agents, narcotics, neuromuscular blocking agents, and maintenance with nitrous oxide (50 to 70%) with volatile anesthetic.
Patient is scheduled to receive postoperative opioids by IM or IV route, or by IV patient-controlled analgesia.
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
Patient is expected to receive propofol for maintenance of anesthesia.
Placement of a nasogastric or oral gastric tube intra or postoperatively (patients should be excluded if these are routinely used for the type of surgery to be performed.)
Patient is expected to receive neuroaxial anesthesia/analgesia (patients should be excluded if neuroaxial anesthesia/analgesia is routinely used for the type of surgery to be performed.)
Please see Protocol for additional criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method