Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06087510

Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

Led by Peking University First Hospital · Updated on 2025-07-30

312

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 6518 years and body weight6540 kg
  • Scheduled to undergo scoliosis correction with pedicle screw fixation
  • Required patient-controlled intravenous analgesia (PCIA) after surgery
Not Eligible

You will not qualify if you...

  • 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 653III
  • 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 654
  • Barrier in communication
  • Other conditions that were considered unsuitable for study participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beijing University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

D

Dong-Xin Wang, MD, PhD

CONTACT

F

Fan Cui, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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