Tokyo, Sept. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059195) titled 'Optimal anesthesia for bladder cancer surgery using 5-aminolevulinic acid' on Sept. 25.
Study Type:
Observational
Primary Sponsor:
Institute - Kochi University
Condition:
Condition - bladder cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Investigation of anesthesia methods used in bladder cancer surgery that can alleviate hypotension caused by 5-aminolevulinic acid.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - We will review the medical records and anesthesia records preserved at our hospital from January 1, 2018, to December 31, 2024, for patients who underwent bladder cancer surgery using 5-aminolevulinic acid (5-ALA) during this period. From these records, we will extract data on anesthesia methods and intraoperative blood pressure values to detect the frequency and severity of intraoperative hypotension. Patients will be categorized into three groups based on anesthesia method: general anesthesia, general anesthesia with remimazolam, and spinal anesthesia. The extracted hypotensive events will then be analyzed within each group to evaluate the primary and secondary endpoints.
Key exclusion criteria - non
Target Size - 425
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 25 Day
Date of IRB - 2025 Year 09 Month 25 Day
Anticipated trial start date - 2025 Year 09 Month 26 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060234
Disclaimer: Curated by HT Syndication.
