Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058870) titled 'Association Between Cumulative Triple Low Duration (Intraoperative Hypotension, Low BIS Values, and Low Inhaled Anesthetic Concentrations) and Postoperative Outcomes and Preoperative Frailty in Patients Undergoing Transcatheter Aortic Valve Replacement: A Retrospective Observational Study' on Aug. 25.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka Metropolitan University
Condition:
Condition - Severe aortic valve stenosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study investigates whether the cumulative duration of triple low (intraoperative hypotension, low BIS, and low anesthetic concentration) during anesthesia is associated with preoperative frailty and postoperative outcomes, such as delirium, complications, hospital stay, and 30-day mortality in elderly patients undergoing TAVI for severe aortic stenosis.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 16
years-old
<
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who underwent planned transcatheter aortic valve implantation for severe aortic stenosis at our hospital between December 2023 and April 2025
Key exclusion criteria - 1. Patients with missing BIS measurements during anesthesia for 15 minutes or more
2. Patients undergoing concurrent surgery
3. Patients with coexisting neuromuscular diseases
Target Size - 376
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2021 Year 05 Month 01 Day
Anticipated trial start date - 2025 Year 08 Month 22 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066658
Disclaimer: Curated by HT Syndication.
