NCT05950646 Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality
| NCT ID | NCT05950646 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Old Age |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 154 participants in total. It began in 2023-11-01 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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-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.
Eligibility Criteria
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.
Contact & Investigator
Dong-Xin Wang, MD,PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT05950646 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 90 Years, studying Old Age. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05950646 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05950646 currently recruiting?
Yes, NCT05950646 is actively recruiting participants. Contact the research team at wangdongxin@hotmail.com for enrollment information.
Where is the NCT05950646 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT05950646 clinical trial?
NCT05950646 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang, MD,PhD at Peking University First Hospital. The trial plans to enroll 154 participants.