Dexmedetomidine-esketamine Combination and Chronic Postsurgical Pain After Spinal Surgery (NCT07525999) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Dexmedetomidine-esketamine Combination and Chronic Postsurgical Pain After Spinal Surgery
China274 participantsStarted 2026-04
Plain-language summary
Spinal surgery is generally followed by severe postoperative pain, and poor pain control may cause adverse outcomes such as cardiovascular events, neurocognitive disorders, and chronic postsurgical pain (CPSP). In previous studies, perioperative use of dexmedetomidine or esketamine is each associated with improved analgesia after surgery. Recent studies suggest that combined use of dexmedetomidine and esketamine may produce synergetic effects in improving analgesia. This trial is designed to test the hypothesis that perioperative combined use of dexmedetomidine and esketamine may reduce CPSP in patients after spinal surgery.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Aged \>= 40 years and \< 80 years;
✓. Scheduled to undergo elective posterior cervical, thoracic or lumbar spine surgery under general anesthesia, with an expected operative duration \>= 2 hours;
✓. Requirement for patient-controlled intravenous analgesia (PCIA) postoperatively.
Exclusion criteria
✕. Severe uncontrolled hypertension preoperatively (baseline ward blood pressure: SBP \> 180 mmHg or DBP \> 110 mmHg);
✕. Severe bradycardia (heart rate \<= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, or a history of myocardial infarction within one year, severe heart failure (NYHA class \>= III), or rapid ventricular arrhythmia;
✕. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;
✕. Preoperative history of hyperthyroidism or pheochromocytoma;
✕. Inability to communicate preoperatively due to coma, severe dementia, or language impairment;
What they're measuring
1
Incidence of chronic pain at 3 months after surgery
✕. Severe cardiac insufficiency (preoperative LVEF \< 30% or NYHA class IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or ASA physical status \>= grade IV;
✕. Other conditions deemed inappropriate for study participation by the investigator or attending physician.