UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051512 |
|---|---|
| Receipt number | R000058766 |
| Scientific Title | Comparison of the preventive effect of ondansetron and dexamethasone on nausea and vomiting after orthognathic surgery between remimazolam and propofol anesthesia. |
| Date of disclosure of the study information | 2023/07/03 |
| Last modified on | 2025/01/08 19:37:00 |
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Basic information
Public title
Comparison of the preventive effect of ondansetron and dexamethasone on nausea and vomiting after orthognathic surgery between remimazolam and propofol anesthesia.
Acronym
Comparison of the preventive effect of ondansetron and dexamethasone on nausea and vomiting after orthognathic surgery between remimazolam and propofol anesthesia.
Scientific Title
Comparison of the preventive effect of ondansetron and dexamethasone on nausea and vomiting after orthognathic surgery between remimazolam and propofol anesthesia.
Scientific Title:Acronym
Comparison of the preventive effect of ondansetron and dexamethasone on nausea and vomiting after orthognathic surgery between remimazolam and propofol anesthesia.
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 incidence of PONV when both dexamethasone and ondansetron are administered under propofol or remimazolam anesthesia.
Basic objectives2
Others
Basic objectives -Others
To evaluate the quality of postoperative recovery when both dexamethasone and ondansetron are administered under propofol or remimazolam anesthesia.
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,24h hours later)
Key secondary outcomes
Whether to use rescue anti-emetics (metoclopramide)
The quality of recovery
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
In the propofol group, anesthesia is induced with continuous infusion of propofol at a rate of 4.0 mcg/ml (target effect-site concentration) until loss of consciousness and maintained with a BIS value between 40 to 60.
Interventions/Control_2
In the remimazolam group, anesthesia is induced with continuous infusion of remimazolam at a rate of 12 mg/kg/hr until loss of consciousness and maintained with a BIS value between 40 to 60.
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.
Key exclusion criteria
Under 20 years of age, ASA-PS3 or higher, patient consent not obtained, BMI30 or higher, use of antiemetics within 24h before surgery, taking benzodiazepines, contraindicated for administration of medications used in this study, emergency surgery
Target sample size
80
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 | Ai |
| Middle name | |
| Last name | Nakakuki |
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
anakakuki@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
| 2023 | Year | 07 | Month | 03 | 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
| 2023 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058766
