UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058219 |
|---|---|
| Receipt number | R000066561 |
| Scientific Title | Investigation of the effect of circadian rhythm on body temperature changes before and after general anesthesia |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/19 13:52:30 |
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Basic information
Public title
Investigation of the effect of circadian rhythm on body temperature changes before and after general anesthesia
Acronym
body temperature changes and circadian rhythm before and after general anesthesia
Scientific Title
Investigation of the effect of circadian rhythm on body temperature changes before and after general anesthesia
Scientific Title:Acronym
Body temperature changes and circadian rhythm before and after general anesthesia
Region
| Japan |
Condition
Condition
thoracic surgery cases (malignancy/no malignancy)
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether circadian rhythm is related to hypothermia during general anesthesia.
Basic objectives2
Others
Basic objectives -Others
To clarify whether hypothermia during general anesthesia is related to circadian rhythm-related body temperature fluctuations.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature when leaving the operating room.
Key secondary outcomes
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
Patients who underwent elective thoracic surgery under general anesthesia at Osaka Metropolitan University Hospital between January 1, 2022 and December 31, 2024
Key exclusion criteria
1. Cases where surgery was performed using only local anesthesia
2. Cases where surgery took 5 hours or more
3. Cases where surgery took less than 1 hour
4. Cases where ASA (America Society of Anesthesiologist) Physical Status was 4 or higher
5. Cases where the patient was under 20 years old on the day of surgery
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Fujimoto |
Organization
Osaka Metropolitan University
Division name
Department of Anesthesiology, School of Medicine
Zip code
5458585
Address
1-4-3, Asahimachi, Abenoku, Osaka City, Osaka
TEL
0666452186
v21794t@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Fujimoto |
Organization
Osaka Metropolitan University
Division name
Department of Anesthesiology, School of Medicine
Zip code
5458585
Address
1-4-3, Asahimachi, Abenoku, Osaka City, Osaka
TEL
0666452186
Homepage URL
v21794t@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
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
Ethics Committee at Osaka Metropolitan University Graduate School of Medicine and Osaka Metropolitan University Hospital
Address
6F Abeno Medix, 1-2-7 Asahimachi, Abenoku, Osaka City, Osaka
Tel
06-6645-3456
graknkyethics@omu.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 | 07 | 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 | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients will be divided into two groups depending on the operating room arrival, whether am or pm. The data from the two groups will be compared.
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066561
