Status:
WITHDRAWN
Nocturnal Low-dose Dexmedetomidine Infusion and Perioperative Sleep Quality
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Beijing Hospital
Conditions:
Old Age
Knee Replacement Surgery
Eligibility:
All Genders
65-90 years
Phase:
NA
Brief 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...
Detailed Description
Sleep is a naturally recurring state characterized by lowered consciousness, reduced sensory and voluntary activity, and inhibited interaction with surroundings. Normal sleep has a particular structur...
Eligibility Criteria
Inclusion
- Age ≥65 years and \<90 years;
- Scheduled to undergo unilateral knee or hip arthroplasty under spinal or combined spinal-epidural anesthesia.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05246007
Start Date
May 1 2022
End Date
December 1 2026
Last Update
August 3 2025
Active Locations (2)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100005
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034