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Nocturnal Low-dose Dexmedetomidine Infusion and Perioperative Sleep Quality

NCT05246007 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-08-03

No results posted yet for this study

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 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. Night-time infusion of low-dose dexmedetomidine may improve sleep quality. However, evidence in this aspect is limited.

Conditions

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

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine will be infused at a rate of 0.02 ml/kg/h (0.025 μg/kg/h) during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).

DRUG

Normal Saline

Placebo (normal saline) will be infused at a rate of 0.02 ml/kg/h during the night before surgery, the night of surgery, and the first 2 nights after surgery (from 9:00 pm-6:00 am).

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
2022-05-31
Primary Completion
2023-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT05246007 on ClinicalTrials.gov