Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
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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