UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054552 |
|---|---|
| Receipt number | R000061025 |
| Scientific Title | Investigating the Usefulness of Notification about Surgery Start Time to Anesthesiologists |
| Date of disclosure of the study information | 2024/06/03 |
| Last modified on | 2025/12/21 20:49:28 |
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Basic information
Public title
Investigating the Usefulness of Notification about Surgery Start Time to Anesthesiologists
Acronym
Investigating the Usefulness of Notification about Surgery Start Time to Anesthesiologists
Scientific Title
Investigating the Usefulness of Notification about Surgery Start Time to Anesthesiologists
Scientific Title:Acronym
Investigating the Usefulness of Notification about Surgery Start Time to Anesthesiologists
Region
| Japan |
Condition
Condition
patients undergoing surgeries under general anesthesia
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the timing or dose of analgesics injection changes if notification about surgery start time is given to anesthesiologists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
last timing of increasing narcotics(remifentanil and fentanyl) before surgery start time
Key secondary outcomes
time interval from draping start to increasing narcotics,
total dosage of narcotics from patient entry to surgery start,
ratio of the mean blood pressure after surgery start to that before surgery start,
expected effect site concentration of narcotics(remifentanil and fentanyl) when surgeries start
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
inform anesthesiologists that the surgery is about to begin when draping starts
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing laparoscopic surgeries under general anesthesia
Key exclusion criteria
severe patients (ASA-PS >=4)
patients who receive any analgesia other than intravenous drugs before surgery start
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Mori |
Organization
Kyoto University Hospital
Division name
Division of Medical Information Technology and Administration Planning
Zip code
606-8507
Address
54 Kawahara-cho, Shogo-in, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-366-7703
yukimori@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Ito |
Organization
Kyoto University Hospital
Division name
Department of Anesthesia
Zip code
606-8507
Address
54 Kawahara-cho, Shogo-in, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-366-7703
Homepage URL
https://kyoto.bvits.com/rinri/publish.aspx
aki0720@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Ito Akihito
Funding Source
Organization
None
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-Cho, Sakyo-ku, Kyoto-shi, Kyoto
Tel
075-753-4642
ethcom@kuhp.kytoo-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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 03 | 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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061025
