Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061068) titled 'Association between Intraoperative Low PSI Exposure During Desflurane Anesthesia and Postoperative Cognitive Changes: A Prospective Observational Study' on April 1.
Study Type:
Observational
Primary Sponsor:
Institute - Hitachi General Hospital
Condition:
Condition - Patients aged 60 years or older undergoing general anesthesia with desflurane
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 60
years-old
=120 minutes; able to complete MoCA-J preoperatively and at POD7; written informed consent obtained
Key exclusion criteria - Known severe dementia or inability to complete MoCA (severe aphasia, visual or hearing impairment); emergency surgery; intracranial surgery or cardiac surgery with CPB; cases changed to predominantly TIVA; cases unable to complete postoperative MoCA-J within specified window
Target Size - 180
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069878
Disclaimer: Curated by HT Syndication.
