NCT06087510 Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes
| NCT ID | NCT06087510 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Scoliosis Correction |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 312 participants in total. It began in 2024-01-24 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 correction surgery is associated with severe pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have antihyperalgesic 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 200 patients after scoliosis correction surgery, mini-dose esketamine-dexmedetomidine in combination with opioids significantly improved analgesia and sleep quality but did not reduce CPSP. The authors speculate that increasing esketamine dose in the combination may further improve analgesia and, therefore, reduce the occurrence of CPSP.
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.
Contact & Investigator
Dong-Xin Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06087510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scoliosis Correction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06087510 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06087510 currently recruiting?
Yes, NCT06087510 is actively recruiting participants. Contact the research team at wangdongxin@hotmail.com for enrollment information.
Where is the NCT06087510 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06087510 clinical trial?
NCT06087510 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang, MD, PhD at Peking University First Hospital. The trial plans to enroll 312 participants.