Tokyo, April 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061214) titled 'Changes in Plasma Remimazolam Concentrations During Cardiac Surgery with Cardiopulmonary Bypass: A Prospective Study' on April 10.
Study Type:
Observational
Primary Sponsor:
Institute - wakayama medical university
Condition:
Condition - Patients undergoing cardiac surgery using cardiopulmonary bypass
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the changes in plasma remimazolam concentrations during cardiac surgery with cardiopulmonary bypass.
Basic objectives2 - Pharmacokinetics
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients undergoing elective cardiac surgery with cardiopulmonary bypass
Patients aged 18 years or older at the time of obtaining informed consent
Patients who have sufficient capacity to understand the study and from whom written informed consent has been obtained
Key exclusion criteria - Emergency surgery
Major vascular surgery
Redo surgery
Patients with a known allergy to remimazolam
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 10 Day
Date of IRB - 2026 Year 02 Month 06 Day
Anticipated trial start date - 2026 Year 04 Month 13 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=R000069910
Disclaimer: Curated by HT Syndication.