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

Study of the Time-Controlled Intravenous Anesthesia Reversal Awakening (TIARA) Method in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1021250019
Enrollment
68
Registered
2025-09-16
Start date
2025-09-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis

Interventions

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

Sponsors

Yaksuhiji Tatsumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Proportion of patients extubated at the target timing

Secondary

MeasureTime frame
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

Contacts

Public ContactTatsumi Yakushiji

Fukushima Medical University Hospital

tatsumiy@fmu.ac.jp+81-8056601302

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026