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Efficacy of Low-Dose S-Ketamine Combined with Dexmedetomidine and Opioids for Postoperative Patient-Controlled Intravenous Analgesia in Adolescents with Scoliosis and Depression Undergoing Orthopedic Surgery: A Single-center, Single-arm, Prospective Study

Efficacy of Low-Dose S-Ketamine Combined with Dexmedetomidine and Opioids for Postoperative Patient-Controlled Intravenous Analgesia in Adolescents with Scoliosis and Depression Undergoing Orthopedic Surgery: A Single-center, Single-arm, Prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120734
Enrollment
Unknown
Registered
2026-03-19
Start date
2026-03-19
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis and Depression

Interventions

Experimental group:Sufentanil + S-ketamine + dexmedetomidine

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1) Age >=13 years and =5 points; 3) Scheduled for elective scoliosis correction surgery (thoracolumbar fusion); 4) ASA (American Society of Anesthesiologists) physical status classification of I-III; 5) Use of patient-controlled intravenous analgesia (PCIA pump) postoperatively; 6) Consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Refusal to participate in this study; 2) Preoperative presence of sick sinus syndrome, severe sinus bradycardia (heart rate = III; 3) Patients with preoperative diagnosis of sleep apnea, or STOP-Bang score (Appendix 1) >= 3 and HCO3- >= 28 mmol/L; 4) Preoperative history of hyperthyroidism or pheochromocytoma; 5) Patients with preoperative schizophrenia, epilepsy, myasthenia gravis, or delirium; 6) Severe hepatic dysfunction (Child-Pugh Class C, Appendix 2); severe renal dysfunction requiring preoperative dialysis; ASA physical status >= IV; 7) Inability to comprehend visual analog scales or presence of language communication barriers; 8) Other conditions deemed unsuitable for study participation by the investigator or attending physician; 9) Preoperative use of ketamine or allergy to ketamine/S-ketamine; 10) Cases requiring high-grade osteotomy (e.g., VCR osteotomy); 11) Current participation in other interventional clinical studies.

Design outcomes

Primary

MeasureTime frame
Incidence of chronic pain at 3 months post-surgery;

Secondary

MeasureTime frame
Incidence of moderate to severe pain within 72 hours postoperatively;Resting and activity-related pain NRS scores at various time points within 3 days postoperatively;;Total opioid consumption within 3 days postoperatively;Cumulative consumption of analgesic drugs within 3 days postoperatively;RASS scores at various time points within 3 days postoperatively;Sleep NRS scores at 3 nights post-surgery, 30 days, and 90 days;Postoperative Hospital Stay;PHQ-9 Depression Score at 7 days, 30 days, and 90 days post-surgery;Total analgesic administration time within 30 days postoperatively;Incidence of complications (including all-cause mortality) within 30 days postoperatively;

Countries

China

Contacts

Public ContactJinhua Bo

Nanjing Drum Tower Hospital

bojinhua@njglyy.com+86 159 5198 7578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026