Overview

Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery

Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
0
Participant gender:
All
Summary
Scoliosis correction surgery is associated with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects and drug tolerance. In a recent trial, mini-dose esketamine and dexmedetomidine combination as a supplement to sufentanil significantly improved analgesia and subjective sleep quality after spinal correction surgery without increasing adverse events; however, the proportion of patients with moderate-to-severe pain remained high. The authors speculate that increasing esketamine dose in the combination may further improve analgesic effects.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University First Hospital
Treatments:
Esketamine
Criteria
Inclusion Criteria:

- Aged ≥18 years and body weight ≥40 kg;

- Scheduled to undergo scoliosis correction with pedicle screw fixation;

- Required patient-controlled intravenous analgesia after surgery.

Exclusion Criteria:

- Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats/min),
atrioventricular block grade II or above without pacemaker; or comorbid with
congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a
cardiac function grade ≥III;

- Patients with moderate and severe obstructive sleep apnea diagnosed preoperatively or
according to the STOP-Bang score;

- History of hyperthyroidism and pheochromocytoma;

- History of schizophrenia, epilepsy, myasthenia gravis, or delirium;

- Severe liver dysfunction (child Pugh grade C), severe renal dysfunction (preoperative
dialysis), or American Society of Anesthesiologists grade ≥IV;

- Barrier in communication;

- Other conditions that are considered unsuitable for study participation.