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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

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 - 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006405
Enrollment
150
Registered
2011-10-07
Start date
2011-11-01
Completion date
Unknown
Last updated
2026-06-29

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

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.

Interventions

Control group: They will receive intraoperative IV droperidol and PCEA without droperidol in combination with fentanyl 4 mcg/mL and ropivacaine 0.06%. Before induction of general anesthesia, an epidur

Sponsors

University of Yamanashi Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Written informed consent, ASA physical status 1 or 2 female patients scheduled to undergo gynecological surgeries under combined general-epidural anesthesia.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative nausea and vomiting at each assessment point Complete responder: No vomiting and use of rescue medications within 3 postoperative days

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactEmi Nakajima

University of Yamanashi, Faculty of University of Yamanashi Hospital Depatment of Anesthesiology

emis@yamanasi.ac.jp055-273-9690

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026