UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062091 |
|---|---|
| Receipt number | R000070934 |
| Scientific Title | A retrospective observational study of anesthesia induction time, associated factors, and anesthesia induction team structure in adult elective surgical patients |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/29 16:22:24 |
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Basic information
Public title
A retrospective observational study of anesthesia induction time, associated factors, and anesthesia induction team structure in adult elective surgical patients
Acronym
Study of Anesthesia Induction Time
Scientific Title
A retrospective observational study of anesthesia induction time, associated factors, and anesthesia induction team structure in adult elective surgical patients
Scientific Title:Acronym
Study of Anesthesia Induction Time
Region
| Japan |
Condition
Condition
Adult elective surgical patients receiving general anesthesia
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the distribution of anesthesia induction time in adult elective surgical patients and to examine the associations of anesthesia induction time with patient characteristics, anesthesia-related factors, anesthesia induction team structure, anesthesia-related procedures, and airway management-related factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anesthesia induction time, defined as the time from operating room entry to the time recorded as end of anesthesia induction in the electronic anesthesia record.
Key secondary outcomes
Factors associated with anesthesia induction time; association between the involvement of peri-anesthesia advanced practice nurses and anesthesia induction time; association between anesthesia induction team structure and anesthesia induction time; and safety-related indicators such as changes in oxygen saturation and blood pressure.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 years or older who underwent elective surgery under general anesthesia.
Key exclusion criteria
Patients who received anesthesia for electroconvulsive therapy; patients who were already intubated at the time of operating room entry; patients who received combined epidural anesthesia or spinal anesthesia; patients who underwent peripheral nerve block between operating room entry and the end of anesthesia induction; and cases in which airway management was clearly performed for educational or training purposes under a system different from the usual anesthesia induction team structure, such as intubation training by emergency medical technicians.
Target sample size
8700
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Department of Fundamental Nursing
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2111
sb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Misuzu |
| Middle name | |
| Last name | Oyagi |
Organization
Shiga University of Medical Science
Division name
Department of Fundamental Nursing
Zip code
520-2129
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2111
Homepage URL
o3rin@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
SUMS Research Ethics Committee
Address
Seta-Tsukinowa, Otsu
Tel
077-548-3576
hqrec@belle.shiga-med.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 | 06 | Month | 30 | 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
| 2026 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 07 | 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 observational study using existing electronic anesthesia records. The study population will consist of consecutive eligible adult elective surgical patients who received general anesthesia between April 1, 2021 and March 31, 2026.
The primary outcome is anesthesia induction time, defined as the time from operating room entry to the time recorded as the end of anesthesia induction in the electronic anesthesia record. This study will examine associations between anesthesia induction time and patient characteristics, anesthesia-related factors, anesthesia induction team structure, anesthesia-related procedures, and airway management-related factors. The association between the involvement of advanced practice nurses in peri-anesthesia care and anesthesia induction time will also be examined.
No intervention will be performed, and no prospective follow-up will be conducted.
Management information
Registered date
| 2026 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070934
