postoperative delirium
Conditions
Interventions
Dexmedetomidine group:Using PCIA pump established with sufentanil 1.25 ug/ml and dexmedetomidine 1.25 ug/ml in normal saline 160 ml for up to 72 hours after surgery. Setup of the PCIA pump: background
Placebo group:Using PCIA pump established with sufentanil 1.25 ug/ml in normal saline 160 ml for up to 72 hours after surgery. Setup of the PCIA pump: background infusion rate 1 ml/h, bolus dose 2 ml,
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 89 Years
Inclusion criteria
Inclusion criteria: Elderly patients aged 65 to 90 years who are scheduled to undergo orthopedic hip/knee replacement surgery or spinal surgery (non-cancer surgery), and planned to use patient-controlled intravenous analgesia (PCIA) after surgery.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded. 1. Refuse to participate in this study; 2. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 3. Inability to communicate in the preoperative period because of coma, profound dementia or language barrier; 4. Preoperative obstructive sleep apnea (diagnosed as obstructive sleep apnea, or STOP-Bang score =3 combined with a serum bicarbonate =28 mmol/L); 5. Preoperative sick sinus syndrome, severe sinus bradycardia (IV, or estimated survival <=24 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium within the first 5 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily prevalence of delirium during the first 5 days after surgery;Length of stay in hospital after surgery;Incidence of non-delirium complications with 30 days after surgery;All-cause 30-day mortality;Quality of life of 30-day survivors: assessed with WHOQOL-BREF;Cognitive function of 30-day survivors: assessed with TICS-m;Overall survival for up to 3 years after surgery;Event-free survival for up to 3 years after surgery;Quality of life in 1-, 2-, and 3-year survivors after surgery assessed with WHOQOL-BREF;Cognitive function in 1-, 2-, and 3-year survivors after surgery assessed with TICS-m; | — |
Countries
China
Contacts
Public ContactWang Dongxin
Peking University First Hospital
Outcome results
None listed