Effect of Mini-dose Dexmedetomidine-Esketamine Infusion on Sleep Quality in Older Patients Undergoing Knee or Hip Replacement Surgery: A Multicenter Randomized Controlled Trial

2023-239

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.

2023-11-01

2024-12-01

2027-12-01

Recruiting

Early phase I

154

Inclusion Criteria: * Age ≥65 years and \<90 years; * Scheduled to undergo unilateral knee or hip arthroplasty. Exclusion Criteria: * Refuse to participate; * Hypnotic therapy for sleep disorders within 3 months; * Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; * Diagnosed as obstructive sleep apnea, or at high risk of moderate to severe obstructive sleep apnea according to the Stop-Bang questionnaire; * Inability to communicate in the preoperative period because of coma, profound dementia, or language barrier; * Sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), or atrioventricular block above grade II without pacemaker implanted; * Severe hepatic dysfunction (Child-Pugh class C), renal dysfunction (required preoperative dialysis), or expected survival ≤24 hours; * Receiving treatment with dexmedetomidine, clonidine, or esketamine; * Allergy to dexmedetomidine or esketamine.

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2023-11-24