UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062448 |
|---|---|
| Receipt number | R000071364 |
| Scientific Title | A Comparison of the Incidence of Postdischarge Nausea and Vomiting (PDNV) Following Outpatient Nasal and Sinus Surgery Using Remimazolam and Sevoflurane: A Multicenter, Prospective, Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/08/17 |
| Last modified on | 2026/08/03 14:40:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Comparison of the Incidence of Postdischarge Nausea and Vomiting.
Acronym
A Comparison of the Incidence of Postdischarge Nausea and Vomiting.
Scientific Title
A Comparison of the Incidence of Postdischarge Nausea and Vomiting (PDNV) Following Outpatient Nasal and Sinus Surgery Using Remimazolam and Sevoflurane: A Multicenter, Prospective, Randomized Controlled Trial
Scientific Title:Acronym
A Comparison of the Incidence of Postdischarge Nausea and Vomiting (PDNV) Following Outpatient Nasal and Sinus Surgery Using Remimazolam and Sevoflurane: A Multicenter, Prospective, Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Same-Day Surgery for the Nose and Sinuses
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether there is a difference in the incidence of PDNV between total intravenous anesthesia using remimazolam and inhalation anesthesia using sevoflurane in same-day nasal and sinus surgeries.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Nausea and Vomiting from Discharge Through the Postoperative Outpatient Visit
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Remimazolam TIVA anesthesia
Interventions/Control_2
sevoflurane 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing same-day nasal and sinus surgery
Adults classified as ASA I or II
Key exclusion criteria
Patients who are pregnant or breastfeeding, or who may be pregnant or breastfeeding
Patients with allergies to benzodiazepines or volatile anesthetics
Patients whose condition is difficult to assess due to cognitive impairment or other factors
Emergency surgical cases
Patients Using Steroids
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | TSUTSUMI |
Organization
Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
7348551
Address
1-2-3 Kasumi Minami Hiroshima
TEL
0822575267
yasuo223@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | TSUTSUMI |
Organization
Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
7348551
Address
1-2-3 Kasumi Minami Hiroshima
TEL
0822575267
Homepage URL
yasuo223@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of SANKA Medical Corporation
Address
6-34-1 Enkoubashi Minami Hiroshima
Tel
082-264-8741
info@carproad.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
| 2026 | Year | 08 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | 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
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071364
