UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055097 |
|---|---|
| Receipt number | R000062940 |
| Scientific Title | Effect of flumazenil administration on nausea and vomiting after oral surgery |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/07/30 09:50:27 |
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Basic information
Public title
Effect of flumazenil administration on nausea and vomiting after oral surgery
Acronym
Effect of flumazenil administration on nausea and vomiting after oral surgery
Scientific Title
Effect of flumazenil administration on nausea and vomiting after oral surgery
Scientific Title:Acronym
Effect of flumazenil administration on nausea and vomiting after oral surgery
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of postoperative nausea and vomiting (PONV) with and without flumazenil under remimazolam anesthesia
Basic objectives2
Others
Basic objectives -Others
To evaluate the quality of postoperative recovery with and without flumazenil under remimazolam anesthesia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of PONV (early period: within 2 hours after the end of anesthesia, late period: 2 - 24 hours after the end of anesthesia)
Key secondary outcomes
Patient background (age, sex, 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)
speed of awakening (time from study drug administration to extubation and MOAA/S score to 5)
degree of PONV (maximum Numerical Rating Scale (NRS) value), presence or absence of vomiting up to 24 hours after the end of anesthesia, number of ondansetron and metoclopramide doses administered
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
Flumazenil group will receive 0.2mg(2mL) of flumazenil after remimazolam anesthesia.
Interventions/Control_2
Flumazenil non-treatment group will receive 2mL of saline after remimazolam anesthesia.
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
Patients undergoing orthognathic surgery
ASA-PS 1-2
Patient who gave consent for this study
Key exclusion criteria
<20 or >50 years of age, ASA-PS 3 or higher, patient who did not give consent for this study,use of antiemetics or benzodiazepines within 24 h before surgery, contraindicated for administration of medications used in this study, emergency surgery
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | kyotarou |
| Middle name | |
| Last name | koshika |
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
koshikakyotarou@tdc.ac.jp
Public contact
Name of contact person
| 1st name | rie |
| Middle name | |
| Last name | katou |
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
rkubota@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 | 08 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062940
