Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063198) titled 'Evaluation of the Safety of Remimazolam in Patients Receiving Long-Term Benzodiazepine Therapy' on Oct. 7.

Study Type: Observational

Primary Sponsor: Institute - Japanese Red Cross Medical Center

Condition: Condition - Surgical patients receiving long-term benzodiazepine therapy who are scheduled for general anesthesia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In patients receiving long-term benzodiazepine therapy, tolerance may lead to an unpredictable anesthetic response to remimazolam, potentially resulting in increased dose requirements and delayed emergence. Furthermore, reversal with flumazenil requires caution because it may precipitate withdrawal symptoms, agitation, or hyperventilation. Hybrid total intravenous anesthesia (Hybrid TIVA), combining remimazolam and propofol, may reduce the required doses and effect-site concentrations of both agents. This approach may consequently minimize prolonged anesthetic effects and reduce the need for flumazenil. This prospective study aims to evaluate the safety and effectiveness of Hybrid TIVA with remimazolam and propofol in patients receiving long-term benzodiazepine therapy. The study will assess the reliability of anesthetic induction and maintenance, time to emergence, frequency of flumazenil administration, and perioperative adverse events. Basic objectives2 - Safety

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - The patients receiving benzodiazepine. Key exclusion criteria - Patients with an ASA physical status of III or higher were excluded. Target Size - 3

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 05 Month 15 Day Date of IRB - 2025 Year 05 Month 15 Day Anticipated trial start date - 2025 Year 05 Month 16 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072132

Disclaimer: Curated by HT Syndication.