Unique ID issued by UMIN | UMIN000006405 |
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Receipt number | R000007600 |
Scientific Title | 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 |
Date of disclosure of the study information | 2011/10/07 |
Last modified on | 2014/08/22 15:23:52 |
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
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
Japan |
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.
Obstetrics and Gynecology | Anesthesiology |
Malignancy
NO
The purpose of this study is to determine if subjects who receive droperidol added to patient-controlled epidural analgesia (PCEA) with fentanyl plus intravenous (IV) droperidol have less post-operative nausea and vomiting (PONV) than those who receive PCEA without droperidol plus IV droperidol only.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Incidence of postoperative nausea and vomiting at each assessment point
Complete responder: No vomiting and use of rescue medications within 3 postoperative days
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Medicine |
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 epidural catheter is inserted at the Th9-10, Th10-11, Th11-12, Th12-L1 or L1-2 interspace. General anesthesia is induced with remifentanil, propofol and rocuronium followed by tracheal intubation. Anesthesia is maintained with sevoflurane, remifentanil and fentanyl without nitro oxide. Intraoperative epidural analgesia is achieved with 1, 1.5, 2 % mepivacaine 4-8 mL bolus injection followed by continuous infusion at 5 mL/h. 1.25 mg of droperidol is given after before the start of operation. On initiation of wound closure, the epidural catheter is connected to a PCEA pump (JMS) is set for a first loading dose 8 mL, a bolus dose of 2 mL, with a 10-min lockout interval, and a background infusion 4 mL/h. PCEA is made a dosage adjustment by attending surgeons and continued to at least the third postoperative day. A blinded investigator visits patients repeatedly to assure adequate analgesia, proper equipment function, and stable vital signs. Data collections are made by the anesthesiologist in attendance and a blind investigator at the end of anesthesia, at 1-5h after the completion of surgery (POD0), in the first postoperative morning (POD1M), in the afternoon (POD1A), in the second postoperative morning (POD2M) and in the third postoperative morning (POD3M).
Droperidol group: They will receive intraoperative IV droperidol and PCEA with droperidol in combination with fentanyl 4 mcg/mL and ropivacaine 0.06%. Before induction of general anesthesia, an epidural catheter is inserted at the Th9-10, Th10-11, Th11-12, Th12-L1 or L1-2 interspace. General anesthesia is induced with remifentanil, propofol and rocuronium followed by tracheal intubation. Anesthesia is maintained with sevoflurane, remifentanil and fentanyl without nitro oxide. Intraoperative epidural analgesia is achieved with 1, 1.5, 2 % mepivacaine 4-8 mL bolus injection followed by continuous infusion at 5 mL/h. 1.25 mg of droperidol is given after before the start of operation. On initiation of wound closure, the epidural catheter is connected to a PCEA pump (JMS) is set for a first loading dose 8 mL, a bolus dose of 2 mL, with a 10-min lockout interval, and a background infusion 4 mL/h. PCEA is made a dosage adjustment by attending surgeons and continued to at least the third postoperative day. A blinded investigator visits patients repeatedly to assure adequate analgesia, proper equipment function, and stable vital signs. Data collections are made by the anesthesiologist in attendance and a blind investigator at the end of anesthesia, at 1-5h after the completion of surgery (POD0), in the first postoperative morning (POD1M), in the afternoon (POD1A), in the second postoperative morning (POD2M) and in the third postoperative morning (POD3M).
20 | years-old | <= |
Not applicable |
Female
Written informed consent, ASA physical status 1 or 2 female patients scheduled to undergo gynecological surgeries under combined general-epidural anesthesia.
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.
150
1st name | |
Middle name | |
Last name | Emi Nakajima |
University of Yamanashi Hospital
Depatment of Anesthesiology
1110,shimokato,Chuo,Yamanashi,409-3898 Japan
055-273-9690
emis@yamanashi.ac.jp
1st name | |
Middle name | |
Last name | Emi Nakajima |
University of Yamanashi, Faculty of University of Yamanashi Hospital
Depatment of Anesthesiology
1110,shimokato,Chuo,Yamanashi,409-3898 Japan
055-273-9690
emis@yamanasi.ac.jp
University of Yamanashi Hospital
None
Self funding
NO
山梨大学医学部付属病院(山梨県)
2011 | Year | 10 | Month | 07 | Day |
Unpublished
Completed
2011 | Year | 07 | Month | 13 | Day |
2011 | Year | 11 | Month | 01 | Day |
2013 | Year | 02 | Month | 15 | Day |
2014 | Year | 02 | Month | 15 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 07 | Month | 31 | Day |
2011 | Year | 09 | Month | 26 | Day |
2014 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007600
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