Remimazolam versus sevofulrane for transcatheter aortic valve implantation; a randomized open label trial

UMIN ID: UMIN000047892

Registered date:01/06/2022

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Severe aortic stenosis
• Date of first enrollment: 2022/06/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Using remimazolam as a sedative for general anesthesia
Using sevoflurane and midazolam as sedatives for general anesthesia

Outcome(s)

• Primary Outcome: Emergence time from general anesthesia (time between cessation of anesthetics and extubation)
• Secondary Outcome: 1. Blood pressure, heart rate, SpO2 during general anesthesia 2. Doses of vasopressors during general anesthesia 3. Intra- and post-operative comprications 4. Respond to verbal stimuli, recovery of muscle strength (tidal volume, and strong hand grip)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Allergic to remimazolam, sevoflurane, midazolam, or flumazenil 2. Past history or family history of malignant hyperthermia 3. Patients with difficulties for participation due to psychologic conditions 4. Patients who are not considered to be feasible

Related Information

• Primary Sponsor: Kagoshima University
• Source(s) of Monetary Support: Kagoshima University