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Study of the Time-Controlled Intravenous Anesthesia Reversal Awakening (TIARA) Method in Patients Undergoing TF-TAVI

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Aortic stenosis
Date of first enrollment	16/09/2025
Target sample size	68
Countries of recruitment
Study type	Interventional
Intervention(s)	In the control group, extubation will be performed after patient awakening at the predetermined target timing. In the TIARA method, maintenance anesthesia will be switched to remimazolam in the latter half of the surgery, and the patient will be rapidly awakened from anesthesia using the antagonist flumazenil at the timing when extubation becomes feasible.

Outcome(s)

Primary Outcome

Proportion of patients extubated at the target timing

Secondary Outcome

1)Modified Aldrete score at 1 minute intervals after extubation, and the time until the modified Aldrete score reaches >7 2)Proportion of patients who exhibited body movement before the completion of surgical procedures 3)Simplified higher brain function assessment at operating room discharge (percentage change from preoperative value) 4)Lowest peripheral oxygen saturation until operating room discharge 5)RASS (Richmond Agitation-Sedation Scale) score in the ICU 6)Incidence of delirium up to postoperative day 1 7)Incidence of postoperative nausea and vomiting up to postoperative day 1 8)Patient satisfaction in a postoperative questionnaire 9)Proportion of patients with recall at the time of extubation

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients scheduled to undergo transfemoral transcatheter aortic valve implantation (TF-TAVI) under general anesthesia who meet all of the following criteria: 1)Patients scheduled to undergo airway management with oral tracheal intubation 2)Patients scheduled for extubation in the operating room 3)Patients who have received sufficient explanation regarding this study and from whom written informed consent has been obtained, either from the patient or a legally authorized representative
Exclude criteria	1)Patients in whom difficult mask ventilation, difficult intubation, or difficult extubation is anticipated 2)Patients at risk of vomiting or aspiration (e.g., esophageal achalasia) 3)Patients with a history of severe allergy to benzodiazepines, flumazenil citrate, remifentanil hydrochloride, naloxone hydrochloride, rocuronium bromide, or sugammadex sodium 4)Patients with a history of tolerance to benzodiazepines 5)Patients with a history of epilepsy 6)Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators