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Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality

NCT05950646 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

  • Old Age
  • Knee Replacement Surgery
  • Hip Replacement Surgery
  • Dexmedetomidine
  • Esketamine
  • Sleep Quality

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.

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD,PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05950646 on ClinicalTrials.gov