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Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

RecruitingPhase 4Ages 18 Years - anyAllPeking University First Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged โ‰ฅ18 years. 2. Scheduled for major noncardiac surgery (โ‰ฅ60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm. 3. Required patient-controlled intravenous analgesia after surgery. Exclusion Criteria: 1. Emergency surgery, transurethral surgery, organ transplantation. 2. Pregnant or lactating women. 3. Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery. 4. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis. 5. Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after neurosurgery. 6. Comorbid with hyperthyroidism and pheochromocytoma. 7. Preoperative left ventricular ejection fraction \<30%, sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), atrioventricular block of degree II or higher without pacemaker implantation, or systolic blood pressure below 90 mmHg despite use of vasopressors. 8. Diagnosed as sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea as assessed by STOP-Bang. 9. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (on dialysis), or ASA classification โ‰ฅIV. 10. Hypersensitive to dexmedetomidine and/or esketamine. 11. Other conditions that are deemed unsuitable for study participation.
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What it tests

  • Dexmedetomidine-esketamine combination
  • Placebo
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Where

1 site
Peking University First Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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