Postoperative Delirium
Conditions
Interventions
Group 1:Remimazolam with total intravenous anesthesia
Group 2:Propofol with total intravenous anesthesia
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 65 and 90; 2. ASA <= Class III; 3. Plan to undergo major non-cardiac surgery, the expected operation time is at least 3 hours, and the expected hospital stay is at least 5 days; 4. BMI between 18-27.9 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed as severe respiratory, cardiovascular, renal or hepatic dysfunction; 2. Hemoglobin < 90 g/L; 3. Have a history of stroke or any other central nervous system disease within 6 months; 4. History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis or other mental diseases; 5. History of alcoholism or psychotropic drug dependence. 6. Unable to communicate due to severe visual, hearing or language problems; 7. Hypersensitivity or contraindications to propofol or benzodiazepines; 8. Preoperative MMSE score < 24 or delirium assessed by 3D-CAM; 9. Participated in other drug trials within 1 month before operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of postoperative delirium within 5 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| the onset time and duration of delirium;cognitive function at discharge;cognitive function within 30 days after surgery;cognitive function within 1 year after surgery;postoperative analgesia within 5 days;postoperative recovery;related inflammatory biomarkers;postoperative chronic pain within 3 months; | — |
Countries
China
Contacts
Public ContactYan Tao
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed