UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061952 |
|---|---|
| Receipt number | R000070887 |
| Scientific Title | Association Between Postoperative Inflammatory Markers and Subjective Sleep on the First Postoperative Night: An Exploratory Secondary Analysis |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/17 22:15:23 |
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Basic information
Public title
Association Between Postoperative Inflammatory Markers and Subjective Sleep on the First Postoperative Night: An Exploratory Secondary Analysis
Acronym
Association Between Postoperative Inflammatory Markers and Subjective Sleep on the First Postoperative Night: An Exploratory Secondary Analysis
Scientific Title
Association Between Postoperative Inflammatory Markers and Subjective Sleep on the First Postoperative Night: An Exploratory Secondary Analysis
Scientific Title:Acronym
Association Between Postoperative Inflammatory Markers and Subjective Sleep on the First Postoperative Night: An Exploratory Secondary Analysis
Region
| Japan |
Condition
Condition
postoperative patients who underwent general anesthesia
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratorily investigate the associations between inflammatory-related markers on postoperative day 1, patient background factors, perioperative factors, and the subjective quality of sleep on the first night after surgery in adult inpatients who underwent elective surgery under general anesthesia.
Basic objectives2
Others
Basic objectives -Others
The secondary objective of this study is to exploratorily identify patient background and perioperative factors that may be associated with subjective sleep quality on the first postoperative night.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the difference in the mean RCSQ score among groups classified according to quartiles of postoperative day 1 CRP levels in the study population.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who participated in the previously conducted study at Kindai University Hospital entitled 'Prevalence Survey of Sleep Disturbance Immediately After Surgery'(Ethics Committee approval number: R07-049) will be included.
Specifically, the study population will consist of adult patients who, in the prospective observational study, underwent elective surgery under general anesthesia, returned to a general ward after surgery, and underwent subjective sleep assessment of the first postoperative night using the Richards Campbell Sleep Questionnaire (RCSQ) on the morning of postoperative day 1.
In the present study, among these patients, cases for which the information required for this study, including C-reactive protein (CRP), neutrophil percentage, and lymphocyte percentage on postoperative day 1, can be obtained from medical records, anesthesia records, nursing records, and blood test results will be included in the analysis.
Key exclusion criteria
Patients who indicate their refusal to participate in this study through the opt-out process.
In addition to the above, patients who are judged by the principal investigator to be inappropriate for participation in this study.
Target sample size
149
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | MINO |
Organization
KINDAI University Hospital
Division name
Department of Nurse anesthetist and Nurse practitioner
Zip code
590-0197
Address
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
TEL
0722887222
takashi.mino@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | MINO |
Organization
KINDAI University Hospital
Division name
Department of Nurse anesthetist and Nurse practitioner
Zip code
590-0197
Address
377-2 Onohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
TEL
072-288-7222
Homepage URL
takashi.mino@med.kindai.ac.jp
Sponsor or person
Institute
KINDAI University Hospital
Institute
Department
Personal name
MINO takashi
Funding Source
Organization
KINDAI University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai Hospital Global Research Alliance Center
Address
1-14-1 Miharadai, Minami-ku, Sakai, Osaka, Japan
Tel
072-288-7222
takashi.mino@med.kindai.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
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 17 | 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 | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 16 | 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
Patient baseline information
Age, sex, and alcohol consumption
Disease-related information
Charlson Comorbidity Index: myocardial infarction, congestive heart failure, peripheral arterial disease, dementia, cerebrovascular disease, chronic pulmonary disease, connective tissue disease, peptic ulcer disease, mild liver disease, diabetes without complications, hemiplegia, moderate to severe renal disease, diabetes with complications, localized solid tumor, leukemia, lymphoma, moderate to severe liver disease, metastatic solid tumor, and AIDS; American Society of Anesthesiologists Physical Status (ASA-PS)
Laboratory data
CRP, neutrophil count, and lymphocyte count on postoperative day 1
Surgical and anesthetic information
Anesthetic maintenance agents (sevoflurane, desflurane, propofol, and Anerem), duration of surgery, Surgical Apgar Score, dose of remifentanil, dose of fentanyl, prophylactic antiemetics, time period of surgery (surgery completed between 8:00 and 13:00 or surgery completed between 13:00 and 19:00), Operative Stress Score2), surgical classification by operative site as defined by the Japanese Society of Anesthesiologists3), presence or absence of nerve block, postoperative analgesic method (none, patient-controlled epidural analgesia, or intravenous patient-controlled analgesia), and blood loss
Postoperative information
Severity of postoperative pain in the ward, assessed using the numerical rating scale (NRS); presence or absence of postoperative nausea and vomiting; use of antiemetics; use of adjuvant analgesics; and Richards-Campbell Sleep Questionnaire (RCSQ)
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070887
