UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059460 |
|---|---|
| Receipt number | R000068000 |
| Scientific Title | A Retrospective Study on the Incidence and Risk Factors of Emergence Agitation Requiring Sedation after General Anesthesia |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/19 16:33:41 |
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Basic information
Public title
A Retrospective Study on the Incidence and Risk Factors of Emergence Agitation Requiring Sedation after General Anesthesia
Acronym
A Retrospective Study on the Incidence and Risk Factors of Emergence Agitation Requiring Sedation after General Anesthesia
Scientific Title
A Retrospective Study on the Incidence and Risk Factors of Emergence Agitation Requiring Sedation after General Anesthesia
Scientific Title:Acronym
A Retrospective Study on the Incidence and Risk Factors of Emergence Agitation Requiring Sedation after General Anesthesia
Region
| Japan |
Condition
Condition
Emergence Agitation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the incidence and associated factors of emergence agitation requiring pharmacologic sedation in patients recovering from general anesthesia.
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the incidence of patients who received anesthetic, psychotropic, or antihistamine medications for sedation to manage emergence agitation between extubation and operating room discharge.
Key secondary outcomes
The secondary outcome was to identify risk factors for emergence agitation using multivariate logistic regression analysis based on patient characteristics, surgical factors, and anesthetic variables.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent general anesthesia at our institution between October 1, 2019, and September 30, 2025, and met the following inclusion criteria:
(1) Patients aged 20 years or older at the time of anesthesia.
(2) Patients who underwent airway management with tracheal intubation or a supraglottic airway device.
Key exclusion criteria
(1) Patients who returned to the ward without extubation after surgery.
(2) Patients who received continuous administration of sedative agents before extubation.
(3) Patients who required re-establishment of the airway in the operating room after extubation.
(4) Patients who had an established airway at the time of entry into the operating room.
(5) Patients deemed inappropriate for inclusion in the study by the principal investigator.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263-37-2670
mitsukuni@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-0807
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
mitsukuni@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
self funding of our department
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
Shinshu University School of Medicine Ethics Committee for Research in Life Sciences and Medicine
Address
3-1-1 Asahi, Matsumoto City, Nagano
Tel
0263-37-3099
mdrinri@shinshu-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 | 01 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aimed to investigate the incidence and background factors of emergence agitation requiring pharmacologic sedation in patients who underwent general anesthesia.
Management information
Registered date
| 2025 | Year | 10 | Month | 19 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068000
