Status:
RECRUITING
Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes
Lead Sponsor:
Peking University First Hospital
Conditions:
Scoliosis Correction
Postoperative Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe acute postoperative pain is one of the major risk factors of CPSP. Spinal ...
Detailed Description
Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Pain can be limited to the surgical area or projected to the innervated area. The...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years and body weight≥40 kg;
- Scheduled to undergo scoliosis correction with pedicle screw fixation;
- Required patient-controlled intravenous analgesia (PCIA) after surgery.
Exclusion
- 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;
- Patients with moderate or severe obstructive sleep apnea diagnosed preoperatively or according to the STOP-Bang score;
- History of hyperthyroidism or pheochromocytoma;
- History of schizophrenia, epilepsy, myasthenia gravis;
- Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anaesthesiologists grade ≥IV;
- Barrier in communication;
- Other conditions that were considered unsuitable for study participation.
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT06087510
Start Date
January 24 2024
End Date
September 1 2026
Last Update
July 30 2025
Active Locations (1)
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1
Beijing University First Hospital
Beijing, Beijing Municipality, China, 100034