Randomized Double Blind Study to Evaluate the Efficacy of Droperidol Added to Patient-Controlled Epidural Analgesia with fentanyl for Prevention of Post-Operative Nausea and Vomiting in Subjects Undergoing Gynecologic Surgery
Not Applicable
- Conditions
- Condition is enough to require surgery under combined general-epidural anesthesia, for example myoma of the uterus, ovarian cyst, denomyosis of the uterus, uterine corpus cancer, uterine cervical cancer, and cancer of ovary et al.
- Registration Number
- JPRN-UMIN000006405
- Lead Sponsor
- niversity of Yamanashi Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
Those have known hypersensitivity to any drugs that is part of this study protocol, contraindications to epidural anesthesia, current opioid use, inability to use the PCEA device, alcohol or narcotic dependence, renal or hepatic insufficiency, QT elongation (QTc interval >450 ms) on preoperative electrocardiogram (ECG) assessment, Parkinsonism, demand premedication, a history of operations under combined general-epidural anesthesia, and a history of severe PONV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of postoperative nausea and vomiting at each assessment point Complete responder: No vomiting and use of rescue medications within 3 postoperative days
- Secondary Outcome Measures
Name Time Method Demographic dates, postoperative pain score, need for supplemental analgesics, severity for PONV, times of PONV episodes, use of antiemetics, presence of motor blockade, the sensory block level, postoperative QTc intervals, volume of the study solution, and other adverse events