Tokyo, June 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061885) titled 'A Study on the Amnesic Effects of Remimazolam' on June 12.

Study Type: Interventional

Study Design: Basic Design - Factorial Randomization - Non-randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - Self-Defense Forces Central Hospital

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In cases of general anesthesia involving invasive procedures (such as epidural anesthesia or brachial plexus block), administering low-dose remimazolam as induction may reduce memories of anxiety and fear without compromising safety. This study examines its efficacy and appropriate administration methods. Basic objectives2 - PK,PD

Intervention: Interventions/Control_1 - After entering the operating room, the patient is fitted with a blood pressure monitor, an electrocardiogram, and a pulse oximeter, and an intravenous line is established. Next, remimazolam is administered so that the concentration at the target site reaches 0.2 micro g/ml within 7 minutes of the administration of local anesthesia. The predicted concentration at the target site 7 minutes after the start of administration is calculated using simulation software to determine the infusion rate. Interventions/Control_2 - Based on the EC95 obtained in Intervention 1, calculate the infusion rate using simulation software to determine the administration method that rapidly achieves the target effect site concentration with both single and continuous dosing.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients in good preoperative condition (ASA-PS 1 or 2) scheduled to undergo general anesthesia with local anesthesia Key exclusion criteria - Dementia History of benzodiazepine use Remimazolam allergy Target Size - 120

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 06 Month 23 Day Date of IRB - 2025 Year 08 Month 14 Day Anticipated trial start date - 2025 Year 09 Month 16 Day Last follow-up date - 2026 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069019

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