Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of two medications, dexmedetomidine and esketamine, can help reduce sleep problems after major noncardiac surgery. Many people experience trouble sleeping after such surgeries, which can slow down their recovery. In earlier research, this combination was found to improve pain relief and sleep quality for patients recovering from scoliosis surgery. The goal of this trial is to see if it can have similar benefits for adults undergoing various types of major surgeries.

To participate in this trial, you need to be at least 18 years old and scheduled for a major surgery that will last at least an hour, using general anesthesia. After the surgery, you will receive pain relief through a patient-controlled intravenous system. However, certain individuals, such as those with specific medical conditions or who are pregnant, won't be eligible. If you join the study, you'll receive the medication during your surgery and be monitored for any effects on your sleep and recovery. This trial is actively recruiting participants, and your involvement could contribute valuable information about improving recovery after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥18 years.
• • 2. Scheduled for major noncardiac surgery (≥60 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 ≥IV.
• • 10. Hypersensitive to dexmedetomidine and/or esketamine.
• • 11. Other conditions that are deemed unsuitable for study participation.