Effect of Flumazenil on Postoperative Memory Retention Time after General Anesthesia with Remimazolam: A Randomized Controlled Trial

UMIN ID: UMIN000052659

Registered date:01/11/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients scheduled for breast surgery under general anesthesia
• Date of first enrollment: 2023/11/01
• Target sample size: 44
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Flumazenil group after general anesthesia
No flumazenil administered after general anesthesia group

Outcome(s)

• Primary Outcome: Time for 80% of patients or all patients in each group to be able to memorize. If the patient had no memory of Illustration A 1 hour after leaving the operating room, one more poster (Illustration B) was shown, and 2 hours after leaving the operating room, the patient's memory of Illustration B was checked. If the patient has no memory of Illustration B, one more poster (Illustration C) is shown, and 3 hours after leaving the operating room, the patient's memory of Illustration C is checked. If the patient remembers Illustration C, the evaluation is terminated at that point.
• Secondary Outcome: (1) Percentage of patients whose memory of the poster shown after awakening from anesthesia could be confirmed 1 hour after leaving the operating room. (2) Dosage and frequency of analgesic use from the time of return to the ward to 3 hours after surgery (3) Dosage and frequency of antiemetic use from the time of return to the ward to 3 hours after surgery

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Female
• Exclude criteria: Patients will be excluded from the study if any of the following apply 1) Patients with a history of hypersensitivity to remimazolam or flumazenil 2. patients with acute angle closure glaucoma, myasthenia gravis, epilepsy patients who have been receiving benzodiazepines for a long period of time, or have a history of serious complications or illnesses that would make them inappropriate for participation in this study Patients who are deemed inappropriate for inclusion in the study by the investigator. 4. (4) Patients with ASA physical status of IV or higher, shock, or coma (5) Patients with cognitive impairment 5. patients with cognitive impairment

Related Information

• Primary Sponsor: Kyushu University Hospital
• Source(s) of Monetary Support: No external funders are not pertained to this manuscript. Funding is provided by self-funding. There are no external funders associated with this manuscript.