Status:
RECRUITING
Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery
Lead Sponsor:
Peking University First Hospital
Conditions:
Scoliosis Correction
Esketamine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Scoliosis correction surgery is associated with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects ...
Detailed Description
Spinal surgery is associated with severe pain, with a median pain score of 7 (interquartile range, 4 to 8) on the first postoperative day, and requires long duration analgesia. The total dose of opioi...
Eligibility Criteria
Inclusion
- Aged ≥18 years and body weight ≥40 kg;
- Scheduled to undergo scoliosis correction with pedicle screw fixation;
- Required patient-controlled intravenous analgesia after surgery.
Exclusion
- Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), atrioventricular block grade II or above without pacemaker; or comorbid with congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a cardiac function grade ≥III;
- Patients with moderate and severe obstructive sleep apnea diagnosed preoperatively or according to the STOP-Bang score；
- History of hyperthyroidism and pheochromocytoma;
- History of schizophrenia, epilepsy, myasthenia gravis, or delirium;
- Severe liver dysfunction (child Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anesthesiologists grade ≥IV;
- Barrier in communication;
- Other conditions that are considered unsuitable for study participation.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT06062550
Start Date
October 24 2023
End Date
October 1 2025
Last Update
July 31 2025
Active Locations (1)
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1
Beijing University First Hospital
Beijing, Beijing Municipality, China, 100034