UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017055 |
|---|---|
| Receipt number | 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 14:39:25 |
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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
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
redhunter-2005-@hotmail.co.jp
Sponsor or person
Institute
Saiseikai Narashino Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019777
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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