Comparison of the incidence of delirium after transfemoral transcatheter aortic valve replacement under monitored anesthesia care with remimazolam versus dexmedetomidine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007245

Enrollment

186

Registered

2022-04-29

Start date

2023-01-02

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

None listed

Interventions

Drug : The dexmedetomidine group receives 1 mg/kg of dexmedetomidine for 10 minutes, followed by 0.3 to 0.7 mg/kg/hour. The remimazolam group receives remimazolam at a rate of 0.2 to 0.6 mg/kg/hour af

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 65 years of age or older who are scheduled to receive transfemoral TAVI under monitored anesthesia care

Exclusion criteria

Exclusion criteria: ?. Patients scheduled for general anesthesia during TAVI ?. Patients undergoing TAVI by a technique other than transfemoral TAVI (e.g., transapical TAVI, transcarotid TAVI, transaortic TAVI, etc.). ?. Patients with preoperative delirium ?. Patients receiving circulatory support before surgery, such as vasopressors, inotropes, and ECMO ?. Patients who have a history of allergy to dexmedetomidine, opioids, or benzodiazepines ?. Patients who are contraindicated to the use of dexmedetomidine, remimazolam, or remifentanil ?. End-stage renal failure patients receiving dialysis ?. Child-Pugh class C liver cirrhosis ?. Patients deemed unsuitable for the study for other reasons by the researcher

Design outcomes

Primary

Measure	Time frame
Delirium incidence after TAVI	—

Secondary

Measure	Time frame
Post-procedure oxygen therapy duration;The use of vasopressors and/or inotropes;Temporary pacemaker placement;Death within 30 days of procedure;Stroke;Acute kidney injury;Pneumonia;Permanent pacemaker implantation;Length of intensive unit stay;Length of hospital stay	—

Countries

Korea, Republic of

Contacts

Public ContactJae-sik Nam

Asan Medical Center

jaesik_nam@naver.com+82-2-3010-3868

Outcome results