Clinical Trial: Can remimazolam administration prevent hypotension during induction? (Japan)

Tokyo, Nov. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059892) titled 'Can remimazolam administration prevent hypotension during induction?' on Nov. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Tokyo Women's Medical University

Condition: Condition - Patients undergoing general anesthesia in the operation room Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Observe through hemodynamic monitoring the extent to which remimazolam can prevent hypotension during induction of anesthesia, comparing it with propofol administration. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Remimazolam is used as the induction agent during anesthesia, and hemodynamic parameters are monitored. Interventions/Control_2 - Propofol is used as the drug for induction of anesthesia, and hemodynamic parameters are monitored.

Eligibility: Age-lower limit - 18 years-old 40 mmHg) or severe mitral regurgitation causing markedly impaired cardiac function, severe pulmonary hypertension (e.g., mean pulmonary artery pressure > 45 mmHg, cases with high risk of right heart failure) 2.Patients with allergies to the induction agent 3.Patients undergoing hemodialysis therapy 4.Patients with severe hepatic impairment (Child-Pugh class C or higher) 5.Patients with atrial fibrillation or atrial/ventricular premature contractions 6.Obese patients with BMI > 35 7.Patients in shock, e.g., mean blood pressure < 70 mmHg prior to anesthesia induction 8.Patients with failed initial oral endotracheal intubation 9.Cases where patient consent cannot be obtained despite family/proxy consent 10.Other patients deemed unsuitable for inclusion by the principal investigator Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 19 Day Date of IRB - 2025 Year 11 Month 19 Day Anticipated trial start date - 2025 Year 11 Month 26 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068493

Disclaimer: Curated by HT Syndication.