UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059617 |
|---|---|
| Receipt number | R000066024 |
| Scientific Title | Clinical Research into the Efficacy of, and Workload Changes due to, the Use of Artificial Intelligence for Preoperative Anesthetic Evaluations |
| Date of disclosure of the study information | 2025/11/02 |
| Last modified on | 2025/11/02 08:34:17 |
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Basic information
Public title
Clinical Research into the Efficacy of, and Workload Changes due to, the Use of Artificial Intelligence for Preoperative Anesthetic Evaluations
Acronym
Clinical Research into the Efficacy of, and Workload Changes due to, the Use of Artificial Intelligence for Preoperative Anesthetic Evaluations
Scientific Title
Clinical Research into the Efficacy of, and Workload Changes due to, the Use of Artificial Intelligence for Preoperative Anesthetic Evaluations
Scientific Title:Acronym
Clinical Research into the Efficacy of, and Workload Changes due to, the Use of Artificial Intelligence for Preoperative Anesthetic Evaluations
Region
| Japan |
Condition
Condition
Adult Patients younger than 90 years old who will undergo general anesthesia for scheduled surgeries and whose American Society of Anesthesiologists Physical Status are either one or two
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the efficacy of, and workload changes due to, the use of Artificial Intelligence (AI) for preoperative anesthetic evaluations.
Basic objectives2
Others
Basic objectives -Others
We evaluate the patients' degrees of understanding and satisfaction for preoperative anesthetic evaluations and interests and questions for general anesthesia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total amount of time (seconds) for preoperative anesthetic evaluations, the amount of time (seconds) for both anesthetic questionnaire and watch video, meaning the time AI was involved, and Questionnaire surveys for anesthesiologists and a medical processor
Key secondary outcomes
Questionnaire surveys for Patients in order to investigate the degrees of understanding and satisfactions for preoperative anesthetic evaluations, and check the counts for patients to click the button saying the reason for asking this question in order to investigate how interested in general anesthesia patients are and what kinds of questions patients have.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Preoperative anesthetic questionnaire using AI
Interventions/Control_2
Conventional anesthetic questionnaire by a medical processor
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult Patients who will undergo general anesthesia for scheduled surgeries and whose ASA PS are either one or two
Key exclusion criteria
The patients with cognitive disorders, visual deficit, and hearing disorders.
The patients who can not communicate in Japanese.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Niiyama |
Organization
Akita University Graduate School of Medicine
Division name
Department of Anesthesia and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita City, Akita prefecture
TEL
018-884-6135
ayanooreilly@gmail.com
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Sekigawa |
Organization
Akita University Graduate School of Medicine
Division name
Department of Anesthesia and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita City, Akita prefecture
TEL
018-884-6135
Homepage URL
ayanooreilly@gmail.com
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita 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
Akita University Life Science ta University Life Science Promotion Devision
Address
1-1-1, Hondo, Akita City, Akita Prefecture, 010-8543
Tel
018-884-6461
soken@hos.akita-u.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 | 11 | Month | 02 | 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
100
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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066024
