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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000040178
Receipt No. 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

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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
Email 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
Email vollock9@gmail.com

Sponsor
Institute Department of Anesthesiology and Pain medicine, Seoul National University Bundang Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045807

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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