Esketamine combined with dexmedetomidine to improve sleep after hip fracture surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Older patients having hip fracture surgery are randomly assigned to receive either an infusion of esketamine plus dexmedetomidine or a matching saline infusion starting after neuraxial anesthesia and continuing for 48 hours. Baseline and postoperative measures include sleep quality (PSQI), delirium screening (3D-CAM), cognitive testing (MoCA), mood (HADS), and pain scores (FPS-R and NRS), along with routine labs. Morphine is given epidurally at surgery start in both groups, and long-term cognitive and recovery outcomes are followed by telephone. The protocol is conducted at a single center with in-hospital monitoring during the infusion period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Principal investigator: Tao Luo, MD,PhD — Peking University Shenzhen Hospitai
• Study coordinator: Tao Luo, MD,PhD
• Email: luotao_wh@yahoo.com
• Phone: 13510820779

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.