Esketamine dose levels combined with dexmedetomidine to reduce pain after scoliosis correction
Official title: 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
Run by Peking University First Hospital · NCT06087510 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 312 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 24, 2024 |
| Main results expected | December 2025 |
| Study ends | September 2026 |
| Registry record updated | July 30, 2025 |
| Trial ID | NCT06087510 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: wangdongxin@hotmail.com
- Phone: 8610-83572784
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Dexmedetomidine or Clonidine added to spinal anesthesia for cesarean delivery
This study tests whether adding dexmedetomidine or clonidine to spinal anesthesia for cesarean delivery improves intraoperative comfort and analgesia.
-
Intranasal dexmedetomidine‑esketamine for pain relief after adenoid and tonsil surgery in children
This trial will test whether giving children aged 3–7 a combined dexmedetomidine and esketamine nasal dose reduces pain after adenoid and tonsil surgery.
-
Dexmedetomidine and esketamine given around surgery to improve recovery after general anesthesia
This trial will test whether giving dexmedetomidine, esketamine, or both during the perioperative period helps adults recover better after surgery under general anesthesia.
-
Remimazolam, dexmedetomidine, or esketamine to calm young children before surgery
This trial will test which of three drugs—remimazolam, dexmedetomidine, or esketamine—best calms children aged 2–5 before adenotonsillectomy and reduces postoperative agitation.
-
Combining dexmedetomidine and esketamine to improve sleep after major surgery
This study is testing whether a mix of two medications, dexmedetomidine and esketamine, can help adults sleep better after major surgery compared to a placebo.
-
Using dexmedetomidine and esketamine for sedation in young children before surgery
This study tests if a combination of two medications, dexmedetomidine and esketamine, can help young children feel calm and relaxed before surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.