Status:
COMPLETED
Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia
Lead Sponsor:
Peking University First Hospital
Conditions:
Scoliosis Correction
Postoperative Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 an...
Detailed Description
Scoliosis correction surgery is followed with severe pain. The reported median pain score on the first day after surgery is median 7 (IQR 4, 8); with an incidence of persistent postoperative pain from...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04791059
Start Date
April 9 2021
End Date
October 7 2022
Last Update
December 13 2022
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034