RecruitingPhase 4NCT06062550

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

Efficacy of Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery: A Randomized, Double-blind Trial


Sponsor

Peking University First Hospital

Enrollment

312 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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.

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Interventions

DRUGEsketamine

Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative intravenous analgesia.


Locations(1)

Beijing University First Hospital

Beijing, Beijing Municipality, China

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NCT06062550


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