Postoperative Sleep Disturbances,PSD
Conditions
Interventions
E Group:Intraoperatively, patients received a continuous infusion of esketamine at 0.2 mg/kg/h with a concomitant, volume-matched infusion of normal saline.
D Group:Intraoperatively, patients received a continuous infusion of dexmedetomidine at 0.2 µg/kg/h with a concomitant, volume-matched infusion of normal saline.
DE Group:Intraoperatively, patients received a continuous infusion of dexmedetomidine at 0.2 µg/kg/h in combination with esketamine at 0.2 mg/kg/h.
Sponsors
The Second Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients scheduled for elective total hip arthroplasty; 2. Aged between 60 and 80 years; 3. BMI between 18 and 30 kg/m²; 4. No severe preoperative sleep disturbance (defined as PSQI <= 11); 5. American Society of Anesthesiologists (ASA) physical status class I–III; 6. Informed consent form signed by the patient or legal representative.
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational drug(s); 2. Use of sedatives, antidepressants, or hypnotics within one month prior to surgery; 3. Sick sinus syndrome, type II second-degree or third-degree atrioventricular block; sinus bradycardia; uncontrolled hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg); 4. Diagnosed sleep apnea syndrome; 5. History of abnormal surgical or anesthetic recovery; 6. Severe psychiatric disorder, cognitive dysfunction, or speech/hearing/visual impairment that hinders assessment; 7. Comorbid severe cardiac or pulmonary insufficiency, severe hepatic insufficiency, severe renal insufficiency, etc.; 8. Participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective sleep quality score on the first postoperative night; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective sleep quality scores on the night before surgery, the second, and third postoperative nights;Pittsburgh Sleep Quality Index score at 1 month postoperatively;Postoperative pain score;Postoperative adverse events;Postoperative anxiety and depression scores; | — |
Countries
China
Contacts
Public ContactMingjian Kong
The Second Affiliated Hospital of Xuzhou Medical University(Xuzhou Mining Group General Hospital)
Outcome results
None listed