Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06859892

Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

Led by Peking University First Hospital · Updated on 2025-03-19

476

Participants Needed

1

Research Sites

89 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.

CONDITIONS

Official Title

Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Scheduled for major noncardiac surgery lasting at least 60 minutes under general anesthesia
  • Surgery expected to end by 6:00 PM on the day of surgery
  • Requires patient-controlled intravenous analgesia after surgery
Not Eligible

You will not qualify if you...

  • Emergency surgery, transurethral surgery, or organ transplantation
  • Pregnant or breastfeeding women
  • Use of hypnotics for sleep disturbances or antidepressants for depression before surgery
  • History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
  • Unable to communicate due to coma, severe dementia, speech disorders, hypoxic encephalopathy, traumatic brain injury, or after neurosurgery
  • Having hyperthyroidism or pheochromocytoma
  • Preoperative left ventricular ejection fraction below 30%, sick sinus syndrome, severe sinus bradycardia (heart rate below 50 beats/min), atrioventricular block of degree II or higher without pacemaker, or systolic blood pressure below 90 mmHg despite vasopressors
  • Diagnosed with sleep apnea or high risk of moderate-to-severe sleep apnea by STOP-Bang assessment
  • Severe liver dysfunction (Child-Pugh class C), severe kidney dysfunction (on dialysis), or ASA classification IV or higher
  • Allergic to dexmedetomidine or esketamine
  • Other conditions making participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, China, 100034

Actively Recruiting

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Research Team

M

Mo Li, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery | DecenTrialz