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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 90
Healthy Volunteers: f
View:

• Age ≥65 years and \<90 years;

• Scheduled to undergo unilateral knee or hip arthroplasty.

Locations
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Dong-Xin Wang, MD,PhD
wangdongxin@hotmail.com
86 10 83572784
Backup
Shuang-Jie Cao, MD
caosjie@bjmu.edu.cn
+86 13651119431
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 154
Treatments
Experimental: Dexmedetomidine-esketamine combination
Dexmedetomidine-esketamine combination will be infused at a rate of 0.01 ml/kg/h (dexmedetomidine 0.02 μg/kg/h and esketamine 5 μg/kg/h) from 8 pm in the night before surgery until 8 am in the third morning after surgery.
Placebo_comparator: Normal saline
Placebo (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.
Sponsors
Collaborators: Beijing Hospital
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov