Postoperative anterograde amnesia by remimazolam and antagonism with flumazenil

UMIN ID: UMIN000051924

Registered date:18/08/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients who will undergo general anesthesia for elective surgery of lower limbs
• Date of first enrollment: 2024/12/21
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

administration of flumazenil
administration of normal saline (placebo)

Outcome(s)

• Primary Outcome: Change of memory test by flumazenil
• Secondary Outcome: Time course of the score in memory test, Incidence of retrograde amnesia/ postoperative delirium/ postoperative sleep disorder

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1) Patients contraindicate or with allergy to remimazolam or flumazenil (2) Patients contraindicate to neuraxial block (3) Patients with cognitive impairment (4) Patients with intracranial disease or cerebrovascular disease (5) Patients who take psychiatric medication (6) Patients who usually take benzodiazepine (7) ASAPS 3 or 4 (8) Patients decided not to be eligible for this study (9) Patients administrated flumazenil for clinical reason (not for research protocol)

Related Information

• Primary Sponsor: Tohoku University
• Source(s) of Monetary Support: No funding sourse