UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061068 |
|---|---|
| Receipt number | R000069878 |
| Scientific Title | Association between Intraoperative Low Patient State Index (PSI) Exposure During Desflurane Anesthesia and Postoperative Cognitive Changes Assessed by Montreal Cognitive Assessment: A Single-Center Prospective Observational Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/04/01 18:21:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Association between Intraoperative Low PSI Exposure During Desflurane Anesthesia and Postoperative Cognitive Changes: A Prospective Observational Study
Acronym
Des-PSI-Cog Study
Scientific Title
Association between Intraoperative Low Patient State Index (PSI) Exposure During Desflurane Anesthesia and Postoperative Cognitive Changes Assessed by Montreal Cognitive Assessment: A Single-Center Prospective Observational Study
Scientific Title:Acronym
DesPSI-MoCA Study
Region
| Japan |
Condition
Condition
Patients aged 60 years or older undergoing general anesthesia with desflurane
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between intraoperative low Patient State Index (PSI) exposure, a processed EEG-derived measure of anesthetic depth, and postoperative cognitive changes, assessed by the change in Montreal Cognitive Assessment score (Change in MoCA = MoCA POD7 - MoCA baseline), in patients undergoing general anesthesia with desflurane.
Basic objectives2
Others
Basic objectives -Others
Association evaluation in a prospective observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in MoCA (MoCA score at postoperative day 7 minus preoperative MoCA score)
Key secondary outcomes
Incidence of clinically meaningful MoCA decline (>=2 points); MoCA subscale scores; incidence of postoperative delirium (POD); delirium duration; QoR-15J (POD2 and POD7)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 60 years or older; elective surgery under general anesthesia maintained primarily with desflurane; expected surgical duration >=120 minutes; able to complete MoCA-J preoperatively and at POD7; written informed consent obtained
Key exclusion criteria
Known severe dementia or inability to perform MoCA-J (aphasia, visual or hearing impairment); emergency surgery; intracranial or cardiac surgery (cardiopulmonary bypass); cases in which maintenance anesthesia was switched primarily to TIVA; cases in which MoCA-J could not be administered within the specified postoperative period; poorly controlled asthma
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | yuichi |
| Middle name | |
| Last name | Yaguchi |
Organization
Hitachi General Hospital, Department of Anesthesiology
Division name
Department of Anesthesiology
Zip code
317-0077
Address
2-1-1, Jonan-cho, Hitachi-shi, Ibaraki, 317-0077, Japan
TEL
0294-23-1111
tamayama66433@gmail.com
Public contact
Name of contact person
| 1st name | Yamato |
| Middle name | |
| Last name | Tamakawa |
Organization
Hitachi General Hospital, Department of Anesthesiology
Division name
Department of Anesthesiology
Zip code
317-0077
Address
2-1-1, Jonan-cho, Hitachi-shi, Ibaraki, 317-0077, Japan
TEL
08066433621
Homepage URL
tamayama66433@gmail.com
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Tamakawa Yamato
Funding Source
Organization
Hitachi General Hospital
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
Hitachi General Hospital Ethics Review Committee
Address
2-1-1, Jonan-cho, Hitachi-shi, Ibaraki, 317-0077, Japan
Tel
0294-23-1111
tamayama66433@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
日立総合病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a single-center prospective observational study. Patients aged 60 years or older undergoing surgery under desflurane general anesthesia are enrolled. The study examines the association between intraoperative low Patient State Index (PSI) exposure, measured by SEDLine EEG monitoring, and the change in MoCA-J score on postoperative day 7. No intervention is performed; all data are collected within the scope of routine clinical care.
Management information
Registered date
| 2026 | Year | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069878
