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

Investigation of the effects of remimazolam and propofol on the autonomic nervous system of patients undergoing TAVI under general anesthesia; Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052230204
Enrollment
28
Registered
2024-03-13
Start date
2024-04-05
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

Randomization will be used to select remimazolam or propofol as the general anesthetic.

Sponsors

Kotani Taichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 28 patients with moderate to severe aortic stenosis diagnosed by echocardiography undergoing TAVI (Transvalvular Aortic Valve Implantation) under general anesthesia

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactTaichi Kotani

Nara Medical University

tk19830715@gmail.com+81-74-29-8902

Outcome results

None listed

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