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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047706
Receipt No. R000054392
Scientific Title Examination of the effect of ondansetron on the prevention of nausea and vomiting after orthognathic surgery
Date of disclosure of the study information 2022/05/11
Last modified on 2022/05/10

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Basic information
Public title Examination of the effect of ondansetron on the prevention of nausea and vomiting after orthognathic surgery
Acronym Examination of the effect of ondansetron on the prevention of nausea and vomiting after orthognathic surgery
Scientific Title Examination of the effect of ondansetron on the prevention of nausea and vomiting after orthognathic surgery
Scientific Title:Acronym Examination of the effect of ondansetron on the prevention of nausea and vomiting after orthognathic surgery
Region
Japan

Condition
Condition Patients undergoing orthognathic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of ondansetron-dexamethasone combination with ondansetron alone for prevention of PONV.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative nausea attitude,Frequency of vomiting (immediately after the end of anesthesia, 2 hours later, 24 hours later)
Key secondary outcomes Whether to use rescue anti-emetics (metoclopramide)

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 Administer dexamethasone before surgery and ondansetron at the end of surgery.
Interventions/Control_2 Administer dexamethasone before surgery and normal saline 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
18 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Eligible patients meet the criteria of the American Society of Anesthesiologists(ASA) physical status of I-II.
Key exclusion criteria Eligible patients meet the criteria of the American Society of Anesthesiologists(ASA) physical status of 3-5.
Patients without consent.
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Kyotaro
Middle name
Last name Koshika
Organization Tokyo Dental College
Division name Dental Anesthesiology
Zip code 101-0061
Address 2-9-18 Misakicho,Chiyodaku,Tokyo-to 101-0061 Japan
TEL 03-6380-9001
Email koshikakyotarou@tdc.ac.jp

Public contact
Name of contact person
1st name Yuna
Middle name
Last name Kang
Organization Tokyo Dental College
Division name Dental Anesthesiology
Zip code 101-0061
Address 2-9-18 Misakicho,Chiyodaku,Tokyo-to 101-0061 Japan
TEL 03-6380-9001
Homepage URL
Email yunakang@tdc.ac.jp

Sponsor
Institute Tokyo Dental College
Institute
Department

Funding Source
Organization Self funding
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 Tokyo Dental College Ethics Review Board
Address 2-9-18 Misakicho,Chiyodaku,Tokyo-to 101-0061 Japan
Tel 03-6380-9001
Email drinri@tdc.ac.jp

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
2022 Year 05 Month 11 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 Open public recruiting
Date of protocol fixation
2022 Year 01 Month 27 Day
Date of IRB
2022 Year 01 Month 27 Day
Anticipated trial start date
2022 Year 02 Month 02 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 10 Day
Last modified on
2022 Year 05 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054392

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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