Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality

Launched by PEKING UNIVERSITY SHENZHEN HOSPITAL · May 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a combination of two medications, esketamine and dexmedetomidine, affects sleep quality after hip fracture surgery. The goal is to see if this combination helps patients sleep better, manage pain, and maintain good mental clarity after their surgery. Participants will be selected randomly to either receive the medication mix or a placebo, which is a saltwater solution that does not have any active ingredients.

To be eligible for this trial, you need to be at least 65 years old and scheduled for hip fracture surgery using a type of anesthesia that numbs the lower body. You must also be able to sign consent to participate. However, there are some health conditions that would prevent you from joining, such as severe heart issues or certain allergies. If you decide to participate, you can expect to be monitored after your surgery for your sleep, pain levels, and thinking abilities to help researchers understand the effects of the treatments. This trial is currently looking for volunteers to take part, so if you or a family member meet the criteria, it could be a helpful opportunity to improve post-surgery care.

Gender

ALL

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.