UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040178 |
|---|---|
| Receipt number | R000045807 |
| Scientific Title | The antiemetic prophylaxis for the PONV (postoperative nausea and vomiting) in patients undergoing microvascular decompression: a prospective randomized controlled trial |
| Date of disclosure of the study information | 2020/04/16 |
| Last modified on | 2021/04/19 08:53:00 |
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Basic information
Public title
The antiemetic prophylaxis for the PONV (postoperative nausea and vomiting) in patients undergoing microvascular decompression: a prospective randomized controlled trial
Acronym
PONV prevention in patients undergoing MVD
Scientific Title
The antiemetic prophylaxis for the PONV (postoperative nausea and vomiting) in patients undergoing microvascular decompression: a prospective randomized controlled trial
Scientific Title:Acronym
PONV prevention in patients undergoing MVD
Region
| Asia(except Japan) |
Condition
Condition
Healthy adults
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the preventive effect of ramosetron on postoperative nausea and vomiting in patients undergoing microvascular decompression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative nausea and vomiting (PONV) at postoperative 48 hours
Key secondary outcomes
The severity of PONV
antiemetics requirements
PCA consumption
Length of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intervention: Ramosetron (0.3 mg) is administered at the end of surgery
Interventions/Control_2
Control: Normal saline 1cc is administered at the end of surgery
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
| 19 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo elective microvascular decompression
American Society of anesthesiologists grade 1 or 2
Patients > 19 years
Key exclusion criteria
Refuse to participate to the study
Body Mass Index < 18.5 or > 35 kg/m2
History of craniotomy
History of chemotherapy
History of preoperative antiemetics
Severe renal or hepatic dysfunction
Chronic opioid use
Prolonged QTc (>450ms)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jung-Hee |
| Middle name | |
| Last name | Ryu |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
13620
Address
82 Gumi-ro 173beon-gil Bundang-gu, Seongnam-si Gyeonggi-do
TEL
+82-31-787-7497
jinaryu74@gmail.com
Public contact
Name of contact person
| 1st name | Chang-Hoon |
| Middle name | |
| Last name | Koo |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
13620
Address
82 Gumi-ro 173beon-gil Bundang-gu, Seongnam-si Gyeonggi-do
TEL
+82-31-787-3659
Homepage URL
vollock9@gmail.com
Sponsor or person
Institute
Department of Anesthesiology and Pain medicine, Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Korea Co., Ltd.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Korea, Republic of
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul National University Bundang Hospital Institutional Review Board
Address
82 Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Tel
82-31-787-8801~6
snubhirb@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 16 | 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
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Constipation
Abdominal discomfort
Hiccup
Outcome measures
The incidence and severity of PONV
The need for rescue antiemetic
Satisfaction score
Postoperative PCA consumption
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 16 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045807
