RecruitingPhase 4NCT05950646

Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality

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


Sponsor

Peking University First Hospital

Enrollment

154 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dexmedetomidine, a drug called Esketamine, and others for people with dexmedetomidine, esketamine, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 65 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexmedetomidine

Dexmedetomidine will be infused at a rate of 0.01 ml/ kg/h (0.02 μg/kg/h) from 8 pm in the night before surgery until 8 am in the third morning after surgery.

DRUGEsketamine

Esketamine will be infused at a rate of 0.01 ml/ kg/h (5 μg/kg/h) from 8 pm in the night before surgery until 8 am in the third morning after surgery.

DRUGNormal saline

Normal saline will be infused at a rate of 0.01 ml/ kg/h from 8 pm in the night before surgery until 8 am in the third morning after surgery.


Locations(2)

Beijing Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT05950646


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