The Effects of Remimazolam on the Incidence of Post-TAVI Delirium

The Effect of Remimazolam Anesthesia on Postoperative Delirium in Transcatheter Aortic Valve Implantation (TAVI): A Pilot Prospective Observational Cohort Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031250812

Enrollment

Registered

2026-03-13

Start date

2026-04-01

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 valve stenosis Aortic valve stenosis, TAVI, postoperative delirium, remimazolam

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years of age or older Scheduled TAVI (under general anesthesia) Able to obtain written consent (from the patient or authorized representative)

Exclusion criteria

Exclusion criteria: Severe cognitive impairment due to overt dementia rendering communication impossible History of psychiatric disorders (schizophrenia, depression, etc.) or neurological disorders (epilepsy, Parkinson's disease, etc.) Chronic use of benzodiazepine drugs (when discontinuation is difficult) Contraindication or hypersensitivity to flumazenil Severe hepatic impairment (e.g., Child-Pugh C) where significant effects on anesthetic pharmacokinetics are anticipated Presence of active delirium prior to surgery Other cases deemed inappropriate by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Cumulative incidence rate of postoperative delirium during the first 3 days after surgery	—

Secondary

Measure	Time frame
CAM-ICU positive rate (when evaluable)/unevaluable rate (RASS -4/-5, etc.) ICDSC (Intensive Care Delirium Screening Checklist) score Timely delirium diagnosis by psychiatrist based on DSM-5-TR criteria CAM-ICU diagnostic characteristics (sensitivity, specificity, etc.) and agreement (kappa) Completion rate of all scheduled CAM-ICU assessments within 72 hours post-surgery (proportion of patients who completed all delirium screening assessments scheduled during the first 3 postoperative days) and missing data rate Dosage of vasopressors administered Time from cessation of anesthetic administration to extubation Occurrence of postoperative complications (e.g., cerebral infarction, cerebral hemorrhage, transient ischemic attack (TIA), heart failure, severe hypotension, severe arrhythmia, hypoxemia, respiratory complications, bleeding, death, intraoperative/postoperative complication rate (Valve Academic Research Consortium 3)) Length of stay in the ICU, total length of hospital stay Change in frailty index (Clinical Frailty Scale) from preoperative to discharge Exposure matching rate/deviation rate (anesthesiologist's preoperative maintenance drug plan vs. actual maintenance drugs used) Follow-up completion rate (proportion of patients who completed all study assessments scheduled within 3 days postoperatively and by discharge) Temporal changes in postoperative inflammatory markers (e.g., CRP) Incidence of anesthesia-related adverse events (hypotension, bradycardia, respiratory depression, re-sedation, seizures, anaphylaxis, PONV, need for additional flumazenil administration, etc.)	—

Measure

Time frame

CAM-ICU positive rate (when evaluable)/unevaluable rate (RASS -4/-5, etc.) ICDSC (Intensive Care Delirium Screening Checklist) score Timely delirium diagnosis by psychiatrist based on DSM-5-TR criteria CAM-ICU diagnostic characteristics (sensitivity, specificity, etc.) and agreement (kappa) Completion rate of all scheduled CAM-ICU assessments within 72 hours post-surgery (proportion of patients who completed all delirium screening assessments scheduled during the first 3 postoperative days) and missing data rate Dosage of vasopressors administered Time from cessation of anesthetic administration to extubation Occurrence of postoperative complications (e.g., cerebral infarction, cerebral hemorrhage, transient ischemic attack (TIA), heart failure, severe hypotension, severe arrhythmia, hypoxemia, respiratory complications, bleeding, death, intraoperative/postoperative complication rate (Valve Academic Research Consortium 3)) Length of stay in the ICU, total length of hospital stay Change in frailty index (Clinical Frailty Scale) from preoperative to discharge Exposure matching rate/deviation rate (anesthesiologist's preoperative maintenance drug plan vs. actual maintenance drugs used) Follow-up completion rate (proportion of patients who completed all study assessments scheduled within 3 days postoperatively and by discharge) Temporal changes in postoperative inflammatory markers (e.g., CRP) Incidence of anesthesia-related adverse events (hypotension, bradycardia, respiratory depression, re-sedation, seizures, anaphylaxis, PONV, need for additional flumazenil administration, etc.)

—

Contacts

Public ContactTeruaki Kano

Yokosuka General Medical Center

t.kano825@gmail.com+81-570032630

Outcome results