Clinical Trial: Association between intraoperative Patient State Index under remimazolam anesthesia and postoperative cognitive dysfunction: a prospective observational study using the Montreal Cognitive Assessment (Japan)

Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059468) titled 'Association between intraoperative Patient State Index under remimazolam anesthesia and postoperative cognitive dysfunction: a prospective observational study using the Montreal Cognitive Assessment' on Oct. 20.

Study Type: Observational

Primary Sponsor: Institute - Hitachi General Hospital

Condition: Condition - Adult surgical patients undergoing general anesthesia (evaluation of postoperative cognitive dysfunction) Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 40 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 Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 20 Day Anticipated trial start date - 2025 Year 11 Month 01 Day Last follow-up date - 2027 Year 03 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068018

Disclaimer: Curated by HT Syndication.