UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054369 |
|---|---|
| Receipt number | R000061846 |
| Scientific Title | Comparison of the efficacy of ondansetron alone versus ondansetron and dexamethasone in the prevention of nausea and vomiting in patients with airway surgical procedures |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2025/02/25 18:14:59 |
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Basic information
Public title
Comparison of the efficacy of ondansetron alone versus ondansetron and dexamethasone in the prevention of nausea and vomiting in patients with airway surgical procedures
Acronym
Comparison of the efficacy of ondansetron alone versus ondansetron and dexamethasone in the prevention of nausea and vomiting in patients with airway surgical procedures
Scientific Title
Comparison of the efficacy of ondansetron alone versus ondansetron and dexamethasone in the prevention of nausea and vomiting in patients with airway surgical procedures
Scientific Title:Acronym
Comparison of the efficacy of ondansetron alone versus ondansetron and dexamethasone in the prevention of nausea and vomiting in patients with airway surgical procedures
Region
| Japan |
Condition
Condition
Patients undergoing minor oral surgery under general anesthesia(except orthognathic surgery and malignant tumor surgery and nerve repair)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of PONV when ondansetron alone and when dexamethasone and ondansetron are administered together.
Basic objectives2
Others
Basic objectives -Others
To evaluate postoperative recovery when ondansetron is administered alone and when dexamethasone and ondansetron are administered together.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of ponv(early stage:2 hours after the end of anesthesia, last stage:2~24 hours after the end of anesthesia)
Key secondary outcomes
Patient background (age, gender, height, weight, smoking history, and presence or absence of motion sickness/ PONV), surgical and anesthetic factors (operation name, operation time, anesthesia time, total infusion volume, blood loss, intraoperative opioid use, and postoperative opioid use), and (amount of opioid use, postoperative opioid use or not), degree of PONV (NRS maximum value (early: up to 2 hours after the end of anesthesia, late: 2~24 hours after the end of anesthesia), the degree of PONV, and the degree of PONV) ~(age, sex, height, weight, smoking history, history of motion sickness/PONV), presence or absence of vomiting up to 24 hours after the end of anesthesia, number of metoclopramide doses administered, and the number of times the (number of patients), Quality of postoperative recovery(QoR-40).
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
The ondansetron alone group will receive 2ml of saline as the study drug after the end of intubation.
Interventions/Control_2
The ondansetron and dexamethasone group will receive 6.6mg(2ml) of dexamethasone as the study drug after the end of intubation.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients meet the criteria of the ASA-PS of 1-2.
Patient who gave consent for this study
Key exclusion criteria
Under 20 years and over 51 years of age, ASA-PS3 or higher, patient consent not obtained, use of antiemetics within 24h before surgery, contraindicated for administration of medications used in this study, emergency surgery
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Dental College
Division name
Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Misakicyo,Chiyodaku,Tokyo-to 101-0061 Japan
TEL
03-6380-9001
yoshidakaori@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Dental College
Division name
Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Misakicyo,Chiyodaku,Tokyo-to 101-0061 Japan
TEL
03-6380-9001
Homepage URL
nomurarika@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
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 Misakicyo,Chiyodaku,Tokyo-to 101-0061 Japan
Tel
03-6380-9001
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
| 2024 | Year | 05 | Month | 10 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061846
