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Efficacy of low-dose S-ketamine and dexmedetomidine combined with opioids for patient-controlled intravenous analgesia after adolescent scoliosis surgery: a single-center, randomized controlled study

Efficacy of low-dose S-ketamine and dexmedetomidine combined with opioids for patient-controlled intravenous analgesia after adolescent scoliosis surgery: a single-center, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088646
Enrollment
Unknown
Registered
2024-08-22
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

scoliosis

Interventions

Experimental group:Sufentanil+ S-ketamine+ Dexmedetomidine
Control group:Sufentanil

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1)Age 10 or more years and 18 years old or less; 2)Prospective elective scoliosis correction surgery (thoracolumbar fusion); 3)ASA I - III level; 4)Postoperative patient-controlled intravenous analgesia (PCIA); 5)Agreed to participate in this study

Exclusion criteria

Exclusion criteria: 1)Refusal to participate in this study; 2)Preoperative with sick sinus syndrome, severe sinus bradycardia (heart rate < 50 times/min), II degree atrioventricular block and not implanted pacemaker; Or with congenital heart disease with any heart rhythm disorders; Or has other serious cardiovascular disease, cardiac function class III or higher; 3)Patients with preoperative diagnosis of sleep apnea, or STOP-Bang score (Annex 1) =3 and HCO3-=28mmol/L; 4)Preoperative patients with hyperthyroidism, history of pheochromocytoma; 5)Preoperative patients with schizophrenia, epilepsy, myasthenia gravis, delirium; 6)Severe liver dysfunction (Child-Pugh class C, Appendix 2); Severe renal dysfunction (dialysis before operation); ASA grade =IV; 7)Don't understand the visual analogue scale or language communication obstacles 8)Other researchers or competent doctors think not appropriate to the situation of the research; 9)He had already used ketamine before surgery and was allergic to ketamine and S-ketamine; 10)Need to make high-grade bone cutting operation (such as a VCR cut bone) cases; 11)She is participating in other interventional clinical studies

Design outcomes

Primary

MeasureTime frame
The incidence of moderate to severe pain;

Secondary

MeasureTime frame
Resting and active pain NRS score;Total opioid consumption;Cumulative consumption of analgesics;RASS score;The incidence of delirium;Sleep NRS score;Postoperative hospital stay;Depression PHQ - 9, CDI score;Analgesic total time;The incidence of complications (including) for all-cause mortality;

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: Feb 4, 2026