Esketamine dose levels combined with dexmedetomidine to reduce pain after scoliosis correction

Impact of Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia on Long-term Outcomes After Scoliosis Correction Surgery: Follow-up of a Randomized Trial

This study will test whether different doses of esketamine given with dexmedetomidine and opioids can reduce immediate postoperative pain and lower the chance of chronic postsurgical pain in adults having scoliosis correction.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06087510 on ClinicalTrials.gov

What this trial studies

Adults scheduled for scoliosis correction with pedicle screw fixation who require patient-controlled intravenous analgesia will be assigned to receive different doses of esketamine combined with dexmedetomidine as supplemental postoperative analgesia. The study compares pain scores, opioid consumption, sleep quality, and the occurrence of chronic postsurgical pain over follow-up. Esketamine is used for its NMDA-antagonist antihyperalgesic effects while dexmedetomidine provides sedative and analgesic adjunct effects. Outcomes focus on both short-term analgesia and longer-term pain measured at least three months after surgery.

Who should consider this trial

Good fit: Adults aged 18 years or older, weighing at least 40 kg, scheduled for scoliosis correction with pedicle screw fixation and requiring postoperative patient-controlled IV analgesia are the intended participants.

Not a fit: Patients with severe cardiovascular disease, significant obstructive sleep apnea, certain psychiatric or neurologic disorders, severe liver or renal dysfunction, or other listed exclusion conditions would be ineligible and unlikely to benefit from the intervention.

Why it matters

Potential benefit: If successful, this approach could improve acute pain control, reduce opioid needs, and lower the risk of long-term chronic postsurgical pain after scoliosis surgery.

How similar studies have performed: Previous work found that a mini-dose esketamine–dexmedetomidine combination improved analgesia and sleep but did not reduce chronic postsurgical pain, while other studies of perioperative ketamine/esketamine have shown mixed results depending on patient populations.

Eligibility criteria

Inclusion Criteria:

* 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 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;
* 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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD

Conditions Scoliosis Correction; Postoperative Analgesia; Esketamine; Dexmedetomidine; Chronic Postsurgical Pain; Postoperative analgesia