RecruitingNot ApplicableNCT07002723

Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality

Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality in Elderly Patients Undergoing Hip Surgery:A Superiority Randomized Controlled Trail


Sponsor

Peking University Shenzhen Hospital

Enrollment

96 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria3

  • Age≥ 65 years old;
  • Hip fracture surgery under neuraxial anesthesia;
  • Signed informed consent.

Exclusion Criteria8

  • 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.

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Interventions

DRUGEsketamine 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.

DRUGNormal 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.


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07002723


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