Esketamine combined with dexmedetomidineNormal saline
Esketamine combined with dexmedetomidine: After successful neuraxial anesthesia, 0.125mg/kg esketamine and 0.3ug/kg dexmedetomidine are diluted into 30ml of normal saline and continuously pumped for 20 minutes, then connected to a micropump: 15ug/kg/h esketamine 0.02ug/kg/h dexmedetomidine to 96ml saline, continuous amount: 2ml/h, continuous pumping for 48h.
Normal saline: After successful neuraxial anesthesia, 30ml of normal saline was continuously pumped for 20 minutes, followed by a micropump: 96ml of saline, continuous amount: 2ml/h for 48h.
Study 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 saline；
3. The patients' sleep, pain, and cognition are followed up after surgery.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age≥ 65 years old;
* Hip fracture surgery under neuraxial anesthesia;
* Signed informed consent.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
sleep quality — the first postoperative night Richards-Campbell sleep questionnaire (RCSQ) score is used to assess the sleep quality, the total score is 100 point, the lowest score is 0 point, and the highest score is 100 point, with higher scores representing better sleep quality.
Trial sites (1)
Facility
City
Region
Status
Peking University Shenzhen Hospital
Shenzhen
Guangdong
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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