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An Observational Study of Preoperative Cognitive Status, Midazolam Use, and Postoperative Delirium in Elderly Non-Cardiac Surgery Patients

Feasibility of a Real-World Decision-Making Chain for Midazolam Use Stratified by Preoperative Cognitive Status and Its Directional Association with Postoperative Delirium: A Single-Center Prospective Observational Pilot Cohort Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600131408
Enrollment
Unknown
Registered
2026-09-02
Start date
2026-09-07
Completion date
Unknown
Last updated
2026-09-07

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

Conditions

Postoperative Delirium (POD)

Interventions

Sponsors

Yantai Yuhuangding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years; 2.Scheduled to undergo elective or semi-elective non-cardiac surgery at our center; 3.Anesthesia plan includes general anesthesia, either total intravenous anesthesia or combined intravenous-inhalation anesthesia; 4.ASA physical status I–III; expected duration of surgery >= 2 hours; 5.Preoperatively alert and able to complete MoCA, CFS, HADS-A and other preoperative assessments; 6.Written informed consent obtained from the patient or their legally authorized representative;

Exclusion criteria

Exclusion criteria: 1.Preoperative Montreal Cognitive Assessment (MoCA) score below 15; 2.Pre-existing diagnosis of dementia, severe neurological disorders, or severe psychiatric illnesses that may interfere with cognitive assessment, informed consent, or postoperative delirium assessment; 3.Cerebral infarction, cerebral hemorrhage, or other acute central nervous system events within 3 months before surgery; 4.Long-term regular use of benzodiazepines, non-benzodiazepine sedative-hypnotics, or other centrally acting sedatives for > 3 months prior to surgery,which may confound interpretation of midazolam exposure or postoperative delirium assessment; 5.Severe hearing, visual, or language impairment that precludes completion of the scale assessments; 6. Severe hepatic or renal insufficiency that, in the investigator's judgment, may significantly affect perioperative sedative metabolism or study safety; 7.Pre-existing delirium, acute disturbance of consciousness, or significant psychiatric/behavioral abnormalities before surgery; 8.Clear anticipation that no postoperative delirium assessment can be completed, or that postoperative data will be unobtainable; 9. Concurrent participation in another clinical study that may affect the exposure, outcomes, or interpretation of this study; 10.Other conditions deemed inappropriate for enrollment by the investigator;

Design outcomes

Primary

MeasureTime frame
Completion rate of the complete research chain;Incidence of postoperative delirium within 7 days after surgery;

Secondary

MeasureTime frame
Hospital length of stay;Midazolam utilization rate and administration pattern;Preoperative cognitive stratification;PACU length of stay;

Countries

China

Contacts

Public ContactJin Jin

Yantai Yuhuangding Hospital

jj0712@126.com+86 535 6691999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026