Actively Recruiting
Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality
Led by Peking University First Hospital · Updated on 2025-07-30
154
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
B
Beijing Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture who are scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, anxiolytic, and analgesic properties. It exerts sedative effects via activating the endogenous sleep pathways and produces a state like non-rapid eye movement sleep, which is different from opioid- and benzodiazepine-induced sedation. Esketamine is a N-methyl-D-aspartic acid receptor antagonist and has been used as an anesthetic and analgesic. Recent studies showed that low-dose esketamine has anti-depressive and sleep-promoting effects. The investigators suppose that mini-dose dexmedetomidine-esketamine combined infusion at night can improve perioperative sleep quality in patients scheduled for knee or hip replacement surgery.
CONDITIONS
Official Title
Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older and less than 90 years
- Scheduled for unilateral knee or hip replacement surgery
You will not qualify if you...
- Refuse to participate in the study
- Used hypnotic therapy for sleep disorders within the last 3 months
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
- Diagnosed with obstructive sleep apnea or high risk for moderate to severe obstructive sleep apnea
- Unable to communicate before surgery due to coma, severe dementia, or language barrier
- Have sick sinus syndrome, severe sinus bradycardia (heart rate below 50 beats per minute), or atrioventricular block above grade II without a pacemaker
- Severe liver dysfunction (Child-Pugh class C), kidney dysfunction requiring dialysis, or expected survival less than 24 hours
- Currently receiving treatment with dexmedetomidine, clonidine, or esketamine
- Allergic to dexmedetomidine or esketamine
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
D
Dong-Xin Wang, MD,PhD
CONTACT
S
Shuang-Jie Cao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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