Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Scoliosis correction surgery is followed with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects and even drug tolerance. S-ketamine is the pure dextrorotatory enantiomer of ketamine with stronger analgesic effect and less side effects, but mental side effects is a major concern. Dexmedetomidine can be used as an analgesic supplement; it also improves sleep quality in postoperative patients. We hypothesize that low-dose ketamine and dexmedetomidine in combination with opioids may have synergistic effect in analgesia and reduce drug-related side effects. This study aims to explore the effect of low-dose of S-ketamine and dexmedetomidine in combination with opioids for postoperative patient-controlled intravenous analgesia in patients following scoliosis correction surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Dexmedetomidine; Esketamine; Ketamine; Sufentanil

Criteria

Inclusion Criteria:

• Age ≥ 18 years old, body weight ≥ 40 kg;

• Scheduled to undergo scoliosis correction with pedicle screw fixation;

• Planned to use patient-controlled intravenous analgesia after surgery.

Exclusion Criteria:

• Refused to participate in the study;

• 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 obstructive sleep apnea syndrome, or a STOP-Bang score ≥ 3 in combination with a serum HCO3- level ≥ 28 mmol/L;

• 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.