Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality
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
| Condition(s) | Old Age, Knee Replacement Surgery, Hip Replacement Surgery, Dexmedetomidine, Esketamine, Sleep Quality |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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-pr |
| Who can participate | 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 |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Lead sponsor | Peking University First Hospital |
| Locations | Beijing, Beijing Municipality, China; Beijing, Beijing Municipality, China |
| Start date | 2023-11-01 |
| NCT ID | NCT05950646 |
| Official listing | https://clinicaltrials.gov/study/NCT05950646 |