UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062731 |
|---|---|
| Receipt number | R000071827 |
| Scientific Title | Real-world Use of the AsisTIVA Syringe Pump Control Software and Perioperative Outcomes: A Retrospective Observational Study |
| Date of disclosure of the study information | 2026/08/29 |
| Last modified on | 2026/08/29 01:00:54 |
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Basic information
Public title
Real-world Use of the AsisTIVA Syringe Pump Control Software and Perioperative Outcomes: A Retrospective Observational Study
Acronym
AsisTIVA Utilization and Perioperative Outcome Evaluation Study
Scientific Title
Real-world Use of the AsisTIVA Syringe Pump Control Software and Perioperative Outcomes: A Retrospective Observational Study
Scientific Title:Acronym
AsisTIVA Utilization and Perioperative Outcome Evaluation Study
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia using total intravenous anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will retrospectively review cases in which AsisTIVA was used and cases managed with conventional total intravenous anesthesia at Toyama University Hospital to characterize the patients and surgical procedures in which AsisTIVA was used, its utilization and operational status, intraoperative physiological parameters, the use of anesthetic and vasoactive agents, emergence from anesthesia, and postoperative outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient and surgical characteristics of cases in which AsisTIVA was used, as well as patterns of AsisTIVA use, including the proportion of cases in which it was used, the initiation and continuation of automated control, manual interventions, and conversion to manual control.
Key secondary outcomes
1) Distribution of intraoperative physiological parameters and percentage of time within the target ranges
2) Doses of anesthetic agents, neuromuscular blocking agents, reversal agents, and vasoactive agents
3) Time from the end of anesthesia to tracheal extubation and departure from the operating room
4) Intraoperative and postoperative adverse events
5) Postoperative pain, nausea and vomiting, respiratory, cardiovascular, and neurological events, intensive care unit admission, and length of hospital stay
6) Warning alerts, communication errors, device malfunctions, interruptions of automated control, and reasons for non-use
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent surgery at Toyama University Hospital between November 10, 2025, and July 31, 2026
2) Patients aged 20 years or older at the time of surgery
3) Patients who received general anesthesia with total intravenous anesthesia using propofol and remifentanil
Key exclusion criteria
1) Patients with substantial missing data in the anesthesia records or clinical information required for the study
2) Patients for whom the patient or their legally authorized representative declined the use of their data for research after public disclosure of the study information
3) Patients deemed unsuitable for inclusion in the study by the principal investigator for any other reason
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
Organization
Faculty of Medicine, University of Toyama
Division name
Department of Anesthesiology
Zip code
930-0194
Address
Sugitani 2630, Toyama City
TEL
076-434-7377
takazawt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
Organization
Faculty of Medicine, University of Toyama
Division name
Department of Anesthesiology
Zip code
939-2705
Address
Sugitani 2630, Toyama City
TEL
076-434-2315
Homepage URL
takazawt@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
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
Ethics Committee for Clinical and Epidemiological Research, University of Toyama
Address
Sugitani 2630, Toyama City
Tel
076-415-8857
kenrinri@adm.u-toyama.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
| 2026 | Year | 08 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective cohort study of consecutive patients who underwent general anesthesia with total intravenous anesthesia using propofol and remifentanil at Toyama University Hospital between November 10, 2025, and July 31, 2026, and met the eligibility criteria. Patients will be classified into the AsisTIVA group and the non-AsisTIVA group, in which anesthetic administration was manually controlled by anesthesiologists. Patient and surgical characteristics, patterns of AsisTIVA use and operation, intraoperative physiological parameters, perioperative medication use, emergence from anesthesia, adverse events, and postoperative outcomes will be compared between the groups. Associations between AsisTIVA use and perioperative outcomes will be analyzed with adjustment for potential confounders, including patient characteristics, type of surgery, and duration of surgery.
Management information
Registered date
| 2026 | Year | 08 | Month | 29 | Day |
Last modified on
| 2026 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071827
