UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057534 |
|---|---|
| Receipt number | R000065729 |
| Scientific Title | The effect of AsisTIVA on Reducing Anesthesiologists' Workload |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2026/04/06 16:31:29 |
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Basic information
Public title
The effect of AsisTIVA on Reducing Anesthesiologists' Workload
Acronym
The effect of AsisTIVA on Reducing Anesthesiologists' Workload
Scientific Title
The effect of AsisTIVA on Reducing Anesthesiologists' Workload
Scientific Title:Acronym
The effect of AsisTIVA on Reducing Anesthesiologists' Workload
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether the use of automated anesthetic drug administration with AsisTIVA in patients undergoing general anesthesia affects the workload of anesthesiologists
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of anesthesiologist interventions during general anesthesia
Key secondary outcomes
Total dose of anesthetic agents,total dose of vasoactive agents, patient vital signs, total dose of postoperative analgesics, total volume of intravenous fluids administered, percentage of time with BIS values maintained between 40 and 60 during anesthesia, duration of anesthesia, time to emergence from anesthesia, subjective evaluation by the anesthesiologist, heart rate of the anesthesiologist, patient condition at discharge from the operating room
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
| Device,equipment |
Interventions/Control_1
Anesthetic drug adjustments are performed using AsisTIVA.
Interventions/Control_2
Anesthetic drug adjustments are performed by anesthesiologists.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients between 20 and 80 years old with ASA (American Society of Anesthesia) PS (Physical Status) 1-2 scheduled for general anesthesia at Tokushima University Hospital.
Key exclusion criteria
ASA PS3 or higher cases
patients undergoing cardiac or neurosurgical procedures
patients who are unable to provide informed consent
pregnant women
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | HIROKI |
| Middle name | |
| Last name | YONEZAWA |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima 770-8503, Japan
TEL
09077859091
hirohirohiro0102@gmail.com
Public contact
Name of contact person
| 1st name | HIROKI |
| Middle name | |
| Last name | YONEZAWA |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima 770-8503, Japan
TEL
0886337181
Homepage URL
hirohirohiro0102@gmail.com
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima 770-8503, Japan
Tel
0886337181
hirohirohiro0102@gmail.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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 10 | 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
| 2025 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 01 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065729
