Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia and Long-term Outcomes

• Status: Active, not recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe postoperative acute pain is one of major risk factors of CPSP. Spine surgery brings severe postoperative pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have anti-hyperalgesic effects and may reduce CPSP. Dexmedetomidine is a alpha 2-adrenoceptor agonist with sedative, anxiolytic and analgesic effect; it is frequently used as a adjuvant to postoperative analgesia. In a previous trial, 200 patients following scoliosis correction surgery were randomzied to receive opioid analgsia supplemented with either mini-dose esketamine-dexmedetomidine combination or placebo. The results showed that esketamine-dexmedetomidine supplement analgesia significantly improved analgesia and sleep quality after surgery. This study is designed to test the hypothesis that mini-dose esketamine-dexmedetomidine supplemented analgesia may reduce CPSP at 2 years after scoliosis correction surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Dexmedetomidine; Esketamine; Sufentanil

Criteria

Inclusion Criteria:

• Patients aged ≥18 years;

• Scheduled for scoliosis correction surgery;

• Required patient-controlled intravenous analgesia (PCIA) after surgery.

Exclusion Criteria:

• Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats per minute), atrioventricular block grade II or above without pacemaker, congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a New York Heart Association class ≥III;

• Obstructive sleep apnea syndrome, or a STOP-Bang score ≥3 in combination with a serum bicarbonate level ≥28 mmol/L;

• Comorbid hyperthyroidism or pheochromocytoma;

• History of schizophrenia, epilepsy, myasthenia gravis;

• Preoperative delirium or communication barrier;

• Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anaesthesiologists grade ≥IV;

• Body weight <40 kg;

• Enrolled in other clinical studies;

• Loss to follow-up;

• Other conditions that were considered unsuitable for study participation.