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RECRUITING
NCT05950646
PHASE4

Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2023-11-01

Completion Date

2025-12

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine

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.

DRUG

Esketamine

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.

DRUG

Normal 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