A comparative study of anesthetic techniques to reduce transient confusion and memory impairment after cardiac surgery

Comparison of Remimazolam and Propofol for Postoperative Delirium and Long-term Cognitive Outcomes in Cardiac Surgery : A Randomized, Pilot and Feasibility Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011453

Enrollment

Registered

2026-01-13

Start date

2026-03-04

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

None listed

Interventions

Drug : In this study, all participants will receive general anesthesia using a total intravenous anesthesia technique, and anesthetic agents and analgesics will be administered intravenously from the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 65 years or older 2) Patients scheduled to undergo elective cardiovascular surgery requiring cardiopulmonary bypass 3) Patients who have provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1) Pre-existing moderate or severe cognitive impairment or acute confusion (delirium) (1) MMSE score < 24, or (2) Positive result on the preoperative 3D-CAM, or (3) Findings suggestive of acute confusion/delirium documented in the medical record/clinical record within the past 48 hours 2) Severe visual, hearing, or language impairment that may affect neurocognitive testing 3) Inability to understand or perform cognitive assessments and study procedures conducted in Korean 4) History of substance abuse, including alcohol 5) History of receiving general anesthesia within the past 1 year 6) History of adverse reactions to remimazolam or propofol 7) Any other condition that the investigators consider inappropriate for participation in the study

Design outcomes

Primary

Measure	Time frame
Recruitment rate (proportion of patients who meet the eligibility criteria and are successfully enrolled);Rate of neurocognitive assessment completion (the proportion of assessments actually performed at the scheduled time points, including the Seoul Neuropsychological Screening Battery–Core (SNSB-C), Supplementary Assessment Battery, and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)).;Follow-up completion rate (the proportion of patients who completed the cognitive assessment at 12 months after surgery).	—

Measure

Time frame

Recruitment rate (proportion of patients who meet the eligibility criteria and are successfully enrolled);Rate of neurocognitive assessment completion (the proportion of assessments actually performed at the scheduled time points, including the Seoul Neuropsychological Screening Battery–Core (SNSB-C), Supplementary Assessment Battery, and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)).;Follow-up completion rate (the proportion of patients who completed the cognitive assessment at 12 months after surgery).

—

Secondary

Measure	Time frame
Incidence of postoperative delirium ;Long-term cognitive function changes;Association between postoperative delirium and long-term cognitive changes;Prespecified subgroup analysis in patients at high cerebrovascular risk;Intraoperative hemodynamic stability;Changes in cerebral oxygen saturation;Clinical safety	—

Countries

Korea, Republic of

Contacts

Public ContactJu-youn Kim

Uijeongbu Eulji Medical Center, Eulji University

juyoun1012@naver.com+82-31-951-2784

Outcome results