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NCT05718544
Mini-dose Esketamine-dexmedetomidine Supplemented Analgesia and Long-term Outcomes
Conditions: Scoliosis Correction, Postoperative Analgesia, Esketamine, Dexmedetomidine, Chronic Postsurgical Pain
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 199
Sponsor: Peking University First Hospital
Location: China
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 the 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 an alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effect; it is frequently used as an adjuvant to postoperative analgesia.
In a previous trial of the investigators, 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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT05718544). StuddyBuddy aggregates publicly available trial information.