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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017055
Receipt No. R000019777
Scientific Title The study to prevent and reduce postoperative nausea and vomiting due to continuous epidural administration
Date of disclosure of the study information 2015/04/06
Last modified on 2015/04/06

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Basic information
Public title The study to prevent and reduce postoperative nausea and vomiting due to continuous epidural administration
Acronym The effectiveness of epidural droperidol for prophylaxis of postoperative nausea and vomiting: a comparative study of droperidol and adrenaline
Scientific Title The study to prevent and reduce postoperative nausea and vomiting due to continuous epidural administration
Scientific Title:Acronym The effectiveness of epidural droperidol for prophylaxis of postoperative nausea and vomiting: a comparative study of droperidol and adrenaline
Region
Japan

Condition
Condition patients scheduled for abdominal gynecological surgery under general-epidural anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Intravenous droperidol has strong evidence for antiemetic efficacy of doroperidol in high risk patients for prevention of postoperative nausea and vomiting (PONV). However it is not clear whether continuous epidural administration of doroperidol prevent PONV. It has been reported that epidural epinephrine decrease PONV, therefore we prospectively compared the effectiveness of epidural droperidol or epinephrine for prophylaxis of PONV.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the incidences of PONV, the use frequency of the antiemetics
Key secondary outcomes the incidences of cancelling continuous epidural administration for vomiting, the use frequency of the adjuvant analgesic, the incidences of pruritus, the incidences of reduction in blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 epidural administration of 0.2% ropivacaine 200ml, fentanyl 14ml and droperidol 2ml, 4ml/hr of administration rate, and 3ml of bolus injection, during about 50 hours.
Interventions/Control_2 epidural administration of 0.2% ropivacaine 200ml, fentanyl 14ml and epinephrine 0.5ml, 4ml/hr of administration rate, and 3ml of bolus injection, during about 50 hours.
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
18 years-old <=
Age-upper limit
30 years-old >
Gender Female
Key inclusion criteria patients scheduled for abdominal gynecological surgery under general-epidural anesthesia
Key exclusion criteria age<18, >=80, ASA-PS<=3, BMI<=35, QT prolongation, Parkinson's disease, psychiatric history, drug abuser, steroid administration
Target sample size 84

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Toyonaga
Organization Saiseikai Narashino Hospital
Division name Department of Aneasthesia
Zip code
Address 1-1-1, izumicho, narashino-ku, Chiba
TEL 047-473-1281
Email redhunter-2005-@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Toyonaga
Organization Saiseikai Narashino Hospital
Division name Department of Aneasthesia
Zip code
Address 1-1-1, izumicho, narashino-ku, Chiba
TEL 047-473-1281
Homepage URL
Email redhunter-2005-@hotmail.co.jp

Sponsor
Institute Saiseikai Narashino 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 済生会習志野病院(千葉県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 06 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
The incidences rate of PONV were 27.9% (doropeidol group) and 58.1% (epinephrine group), respectively (P=0.0046, odds ratio 0.279, NNT 3.13). The use frequency of the antiemetics were 18.6% and 41.9%, respectively (P=0.0189, odds ratio 0.317, NNT 4.29). There was one patient who had to cancel continuous epidural administration for vomiting in epinephrine group, but no patient in doropeidol group.
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
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 30 Day
Last follow-up date
2014 Year 07 Month 02 Day
Date of closure to data entry
2014 Year 09 Month 30 Day
Date trial data considered complete
2014 Year 10 Month 31 Day
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 06 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019777

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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