Investigation of the effects of anesthetics on the autonomic nervous system of patients undergoing TAVI; RCT

JRCT ID: jRCT1052230204

Registered date:13/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Aortic stenosis
• Date of first enrollment: 13/03/2024
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Randomization will be used to select remimazolam or propofol as the general anesthetic.

Outcome(s)

• Primary Outcome: Percentage change in mean HFVI value for 3 minutes before induction of anesthesia and mean HFVI value for 3 minutes immediately after induction of anesthesia

Secondary Outcome

Changes in hemodynamic parameters during induction of anesthesia
Changes in HFVI values during induction of anesthesia to the start of surgery
Changes in HFVI values during rapid pacing at the time of TAVI valve insertion

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 28 patients with moderate to severe aortic stenosis diagnosed by echocardiography undergoing TAVI (Transvalvular Aortic Valve Implantation) under general anesthesia

Exclude criteria

(1) Patients undergoing local anesthesia TAVI
(2) Patients who cannot speak daily conversation in Japanese
(3) Patients who are unable to consent to the study because they do not understand the study description
(4) Patients with a pre-existing pacemaker implantation or diabetes mellitus with neuropathy who cannot be evaluated for appropriate heart rate variability
(5) Patients who are in atrial fibrillation at the time of admission to the operating room and cannot be evaluated for appropriate heart rate variability
(6) Patients with contraindications to the use of Anerem
(7) Patients with contraindications to the use of 1% Diprivan

Related Information

• Primary Sponsor: Kotani Taichi