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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006405
Receipt No. 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

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Basic information
Public 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
Acronym 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
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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition 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.
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative nausea and vomiting at each assessment point
Complete responder: No vomiting and use of rescue medications within 3 postoperative days
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 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).
Interventions/Control_2 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).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Written informed consent, ASA physical status 1 or 2 female patients scheduled to undergo gynecological surgeries under combined general-epidural anesthesia.
Key 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.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emi Nakajima
Organization University of Yamanashi Hospital
Division name Depatment of Anesthesiology
Zip code
Address 1110,shimokato,Chuo,Yamanashi,409-3898 Japan
TEL 055-273-9690
Email emis@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emi Nakajima
Organization University of Yamanashi, Faculty of University of Yamanashi Hospital
Division name Depatment of Anesthesiology
Zip code
Address 1110,shimokato,Chuo,Yamanashi,409-3898 Japan
TEL 055-273-9690
Homepage URL
Email emis@yamanasi.ac.jp

Sponsor
Institute University of Yamanashi Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 山梨大学医学部付属病院(山梨県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2013 Year 02 Month 15 Day
Date of closure to data entry
2014 Year 02 Month 15 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 09 Month 26 Day
Last modified on
2014 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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