Esketamine combined with dexmedetomidine to improve sleep after hip fracture surgery

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

This will test whether giving esketamine together with dexmedetomidine during and after neuraxial anesthesia helps people 65 and older who have hip fracture surgery sleep better and have less pain and confusion.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Peking University Shenzhen Hospital (Academic / other)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07002723 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 or older undergoing hip fracture surgery under neuraxial anesthesia who can provide informed consent and have no contraindications to esketamine or dexmedetomidine.

Not a fit: Patients with severe cardiovascular disease, obstructive sleep apnea, significant hepatic or renal failure, contraindications to neuraxial anesthesia, or known allergies to the study drugs are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, the drug combination could improve postoperative sleep, reduce pain and delirium, and support better cognitive recovery after hip fracture surgery.

How similar studies have performed: Dexmedetomidine alone has shown some benefit for sleep and delirium prevention in older surgical patients, but combining esketamine with dexmedetomidine is relatively novel with limited prior data.

Eligibility criteria

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 this trial is running

Shenzhen, Guangdong

• 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

Conditions Hip Fractures