UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058961 |
|---|---|
| Receipt number | R000067418 |
| Scientific Title | Exploration of biomarkers for predicting and preventing postoperative nausea and vomiting |
| Date of disclosure of the study information | 2025/09/08 |
| Last modified on | 2025/09/02 09:55:57 |
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Basic information
Public title
Exploration of biomarkers for predicting and preventing postoperative nausea and vomiting
Acronym
Exploration of biomarkers for predicting postoperative nausea and vomiting
Scientific Title
Exploration of biomarkers for predicting and preventing postoperative nausea and vomiting
Scientific Title:Acronym
Exploration of biomarkers for predicting postoperative nausea and vomiting
Region
| Japan |
Condition
Condition
Inpatients undergoing oral surgery under general anesthesia
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to identify indicators that can predict with higher accuracy which patients are at high risk of developing PONV prior to surgery.
Basic objectives2
Others
Basic objectives -Others
Exploration and Identification of Biomarkers Predicting Postoperative Nausea and Vomiting
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary amylase, cortisol, and serotonin prior to general anesthesia
Key secondary outcomes
Postoperative (upon return to room, 3 hours after return to room, the following morning) PONV level VAS assessment, age, gender, height, weight, medical history, presence of preoperative complications, smoking and drinking status, preoperative blood test results, anesthesia duration, surgery duration, administered medications, vital data (ECG, heart rate, blood pressure (non-invasive and invasive arterial pressure), pulse rate, respiratory rate, SpO2, neuromuscular blockade monitor data, fluid administration volume, blood loss volume, and the volume and consistency of gastric contents immediately prior to awakening as measured by the nasogastric tube placed intraoperatively).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients undergoing oral surgery under general anesthesia (men and women classified as ASA physical status 1 or 2)
Key exclusion criteria
Cases with a scheduled surgery time of less than one hour, patients with allergies to the medications used, patients who expressed refusal to participate in this study (including verbally), and other patients deemed unsuitable by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Uno |
| Middle name | |
| Last name | Imaizumi |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology
Zip code
238-8570
Address
1-23 Ogawa-cho, Yokosuka, Kanagawa
TEL
046-822-8896
imaizumi@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Uno |
| Middle name | |
| Last name | Imaizumi |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology
Zip code
238-8570
Address
1-23 Ogawa-cho, Yokosuka, Kanagawa
TEL
046-822-8896
Homepage URL
imaizumi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental 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
Kanagawa Dental University Research Ethics Review Committee
Address
82 Inaoka-cho, Yokosuka, Kanagawa
Tel
046-822-8813
kenkyo@kdu.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
| 2025 | Year | 09 | Month | 08 | 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
| 2025 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients are classified into a high-risk group (scoring 2 points or more on three of the four Apfel Score criteria: female, non-smoker, history of PONV or motion sickness, postoperative opioid use) and a low-risk group (scoring less than 2 points). The general anesthetic agent used is sevoflurane. Anti-emetic drugs such as ondansetron, metoclopramide, and droperidol are not administered until an episode is judged to be PONV. Nitrous oxide, which has emetic effects, is not used. No restrictions are placed on the use of other medications. A nasogastric tube is placed intraoperatively. The observation period is 24 hours postoperatively, during which PONV occurrence is prospectively monitored.
Management information
Registered date
| 2025 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067418
