UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059468 |
|---|---|
| Receipt number | R000068018 |
| Scientific Title | Association between intraoperative Patient State Index under remimazolam anesthesia and postoperative cognitive dysfunction: a prospective observational study using the Montreal Cognitive Assessment |
| Date of disclosure of the study information | 2025/10/20 |
| Last modified on | 2025/10/20 14:45:12 |
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Basic information
Public title
Association between intraoperative Patient State Index under remimazolam anesthesia and postoperative cognitive dysfunction: a prospective observational study using the Montreal Cognitive Assessment
Acronym
Remimazolam-POCD Study
Scientific Title
Association between intraoperative Patient State Index under remimazolam anesthesia and postoperative cognitive dysfunction: a prospective observational study using the Montreal Cognitive Assessment
Scientific Title:Acronym
Remimazolam-POCD Study
Region
| Japan |
Condition
Condition
Adult surgical patients undergoing general anesthesia (evaluation of postoperative cognitive dysfunction)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to clarify the association between intraoperative Patient State Index (PSI) under remimazolam anesthesia and postoperative cognitive dysfunction (POCD), which will be assessed using the Montreal Cognitive Assessment (MoCA) before and after surgery. The secondary objective is to explore the relationship between PSI and postoperative delirium (POD).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the Montreal Cognitive Assessment (MoCA) score between the preoperative and postoperative assessments (at discharge or postoperative day 30), or the incidence of postoperative cognitive dysfunction (POCD).
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Adult patients aged between 20 and 60 years
2. Undergoing open abdominal surgery under general anesthesia
3. Planned use of remimazolam for induction and maintenance of anesthesia
4. Able to complete preoperative cognitive assessment using the Montreal Cognitive Assessment (MoCA)
5. Provided written informed consent to participate in the study
Key exclusion criteria
1. Patients with a preoperative diagnosis of severe cognitive impairment or dementia
2. Patients with a history of psychiatric illness, epilepsy, or neurodegenerative disease3.
3. Patients with hearing or speech impairments that make MoCA assessment difficult
4. Patients undergoing neurosurgical or cardiac surgery
5. Emergency surgery cases
6. Patients who do not provide informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Shiraishi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
317-0077
Address
2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan
TEL
0294-23-1111
tshiraishi.1217@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Shiraishi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
317-0077
Address
2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan
TEL
0294-23-1111
Homepage URL
tshiraishi.1217@gmail.com
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Hitachi General Hospital
Address
2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan
Tel
0294-23-1111
tshiraishi.1217@gmail.com
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 | 10 | Month | 20 | 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 | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single center, prospective observational study to evaluate the association between intraoperative Patient State Index (PSI) under remimazolam anesthesia and postoperative cognitive changes. Adult patients aged 20-60 years undergoing open abdominal surgery will be enrolled. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) before surgery and at discharge or postoperative day 30. PSI will be monitored continuously during anesthesia, and its relationship with anesthetic depth and physiologic parameters (e.g., blood pressure, BIS) will be analyzed. The primary outcomes are the change in MoCA score and the incidence of postoperative cognitive dysfunction (POCD). The secondary outcome is the incidence of postoperative delirium (POD). The planned study period is June 2025 to March 2027.
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068018
