Status:
RECRUITING
Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality
Lead Sponsor:
Peking University Shenzhen Hospital
Conditions:
Hip Fractures
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
1. Eligible patients are randomly divided into experimental and control groups； 2. The experimental group is given esketamine combined with dexmedetomidine，while the control group is given normal sali...
Detailed Description
One day before surgery, the investigators collect baseline data from patients at the bedside. Preoperative sleep quality is assessed using Pittsburgh sleep quality index(PSQI); Three-Minute Confusion ...
Eligibility Criteria
Inclusion
- Age≥ 65 years old;
- Hip fracture surgery under neuraxial anesthesia;
- Signed informed consent.
Exclusion
- ASA classification≥ Class V;
- Presence of neuraxial anesthesia contraindications: coagulation dysfunction, thrombocytopenia, neuraxial mass, puncture site infection, etc.;
- Patients with contraindications to esketamine (such as allergies, intracranial aneurysms, hyperthyroidism and glaucoma);
- Patients with contraindications to dexmedetomidine (allergies);
- Patients with severe cardiovascular diseases such as sick sinus syndrome, severe sinus bradycardia (heart rate \< 50 beats/min), atrioventricular block grade II or above without pacemaker, unstable angina, severe valvular heart disease, severe arrhythmia, severe macrovascular disease with New York Heart Association class III patients, etc.;
- Obstructive sleep apnea syndrome (STOP-BANG score \> 3 points);
- Patients with severe hepatic and renal insufficiency (such as Child-Pugh score III, creatinine clearance \< 35 mL/min, preoperative dialysis);
- Those who have delirium, dementia, moderate to severe cognitive dysfunction and psychiatric disorders before the start of the trial and are unable to communicate and cooperate with the investigator.
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT07002723
Start Date
June 20 2025
End Date
June 30 2026
Last Update
December 5 2025
Active Locations (1)
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1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China