Postoperative delirium
Conditions
Interventions
Remi Group:Intravenous injection of Tolfenamic Acid Remimazolam 0.3mg/kg before anesthesia induction
Mida Group:Intravenous injection of Midazolam Injection 0.05mg/kg before anesthesia induction
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 60 years or older but under 90 years, regardless of gender; 2.Patients scheduled for elective liver resection under general anesthesia; 3.American Society of Anesthesiologists (ASA) Class I to III; 4.Voluntary participation by the patient and their legal representative, with signed informed consent; 5.Patients who have not participated in other drug clinical trials within 3 months prior to screening;
Exclusion criteria
Exclusion criteria: 1.Patients with NYHA class = III, sick sinus syndrome, second-degree or higher AV block, or coagulation disorders; 2.Severe hepatic impairment (Child-Pugh C), severe renal impairment (requiring preoperative dialysis), or severe organic brain disease; 3.Patients with preoperative epilepsy, depression, schizophrenia, Alzheimer's disease, Parkinson's disease, or myasthenia gravis; 4.Severe organ deficits (e.g., visual, auditory, or speech impairments) affecting preoperative visits and testing; 5.Preoperative Mini-Mental State Examination (MMSE) score < 18; 6.Contraindications to midazolam or remimazolam use; 7.Patients on long-term sedative medication or prolonged glucocorticoid therapy; 8.History of alcohol or substance dependence; 9.Other patients deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative delirium (POD) within 7 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE scores at 1 day before surgery, 1 day, 3 days, and 7 days after surgery;Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at 1 day before surgery, immediately after surgery, and 1 day after surgery;Changes in blood pressure and heart rate during anesthesia induction and surgery;Anesthesia- and surgery-related times including anesthesia duration, surgery duration, emergence time, extubation time, and PACU stay duration;Anesthesia and intraoperative conditions including propofol dosage, anesthesia and surgical procedures, and drug types and dosages;Adverse events during and after surgery including intraoperative hypotension, hypertension, bradycardia, tachycardia, arrhythmias, hypoxemia, intraoperative awareness, postoperative nausea and vomiting, dizziness, headache, etc.;Total hospital length of stay and hospitalization costs after surgery; | — |
Countries
China
Contacts
Public ContactChen Chaojin
The Third Affiliated Hospital Sun Yat-sen University
Outcome results
None listed