WithdrawnNot Applicable

Nocturnal Low-dose Dexmedetomidine Infusion and Perioperative Sleep Quality

Stopped: We changed the protocol and registered for another trial.

China0Started 2022-05

Plain-language summary

Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture 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. Night-time infusion of low-dose dexmedetomidine may improve sleep quality. However, evidence in this aspect is limited.

Who can participate

Age range65 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥65 years and \<90 years; * Scheduled to undergo unilateral knee or hip arthroplasty under spinal or combined spinal-epidural anesthesia. Exclusion Criteria: * Refuse to participate; * Hypnotic therapy for sleep disorders within 3 months; * Presence of contraindications to intrathecal anesthesia; * Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or delirium; * 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 (Childe Pugh class C); renal dysfunction (required preoperative dialysis), or expected survival ≤24 hours; * Receiving treatment with dexmedetomidine or clonidine; * Allergy to dexmedetomidine.

What they're measuring

Subjective sleep quality (overall RCSQ score) during the night of surgery.

Timeframe: During the night of surgery.

Trial details

NCT IDNCT05246007

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12