Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery
NCT ID: NCT06062550
Last Updated: 2025-07-31
Study Results
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Basic Information
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RECRUITING
PHASE4
312 participants
INTERVENTIONAL
2023-10-24
2025-10-31
Brief Summary
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Detailed Description
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Ketamine is a non-competitive N-methyl-D-aspartate receptor antagonist. Low-dose ketamine infusion is recommended for postoperative analgesia but may cause neuropsychiatric side effects. Esketamine is the S-enantiomer of racemic ketamine with approximately twice as potent as racemic ketamine in analgesia and less likely to produce side effects. Dexmedetomidine is a highly selective α2 receptor agonist and has anxiolytic, sedative, analgesic effects. When used as a supplement to opioid analgesia, dexmedetomidine improves analgesia and sleep quality but may produce sedation.
In a recent trial, mini-dose esketamine-dexmedetomidine combination as a supplement to sufentanil significantly improved analgesia and subjective sleep quality after scoliosis correction surgery; no significant adverse reactions were observed. However, the proportion of moderate-to-severe pain remained high (65.7%) in these patients, so further improvement is needed. The authors speculate that increasing esketamine dose in the esketamine-dexmedetomidine combination may further improve the analgesia. This study aims to explore the effects of different dose esketamine in the combination on acute and chronic pain in patients following spinal deformity surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Low-dose group
Patient-controlled analgesia is established with esketamine 50 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lockout interval of 8 minutes and a background infusion rate at 1 ml/h.
Esketamine
Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative intravenous analgesia.
Medium-dose group
Patient-controlled analgesia is established with esketamine 100 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lockout interval of 8 minutes and a background infusion rate at 1 ml/h.
Esketamine
Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative intravenous analgesia.
High-dose group
Patient-controlled analgesia is established with esketamine 150 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lockout interval of 8 minutes and a background infusion rate at 1 ml/h.
Esketamine
Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative intravenous analgesia.
Interventions
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Esketamine
Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative intravenous analgesia.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo scoliosis correction with pedicle screw fixation;
* Required patient-controlled intravenous analgesia after surgery.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology
Principal Investigators
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Dong-Xin Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Beijing University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2023-351
Identifier Type: -
Identifier Source: org_study_id
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