Esketamine: Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative intravenous analgesia.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Pain intensity with movement and opioid consumption within 72 hours. — Within 72 hours after surgery A comprehensive index of pain intensity and opioid consumption is calculated. The range of the index is -200% to +200%; values above 0 indicate increased summed area under curve (AUC) and opioid consumption (OC) compared to the all patients.
Trial sites (1)
Facility
City
Region
Status
Beijing University First Hospital
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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