Comparing two anesthesia methods for scoliosis surgery in adolescents
A Prospective Study Comparing Total Intravenous Anesthesia With Propofol and Remifentanil vs. Propofol and Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion and Instrumentation
This study tests which of two anesthesia combinations works better for pain management and recovery in teenagers having surgery for scoliosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06096181 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two total intravenous anesthesia (TIVA) combinations in adolescents with Adolescent Idiopathic Scoliosis undergoing posterior spinal fusion surgery. Participants will be randomly assigned to receive either Propofol with Remifentanil or Propofol with Dexmedetomidine. The study seeks to evaluate the effectiveness and safety of these combinations, particularly focusing on the potential for opioid-induced hyperalgesia associated with Remifentanil. The goal is to determine which combination provides better pain management and recovery outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 years with a diagnosis of Adolescent Idiopathic Scoliosis who are scheduled for posterior spinal fusion surgery.
Not a fit: Patients with neuromuscular scoliosis or those allergic to any of the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for adolescents undergoing scoliosis surgery.
How similar studies have performed: While the use of Dexmedetomidine in pediatric patients is off-label, similar studies in adults have shown promising results, indicating potential for success in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 12-18 years old * American Society of Anesthesiology Physical Status Classification (ASA Class) 1 and 2 * Have diagnosis of Adolescent Idiopathic Scoliosis * Undergoing Posterior Spinal Fusion with instrumentation for scoliosis correction * Matched on age, sex, and the number of vertebral levels fused Exclusion Criteria: * Neuromuscular scoliosis * Allergy to any of the multi-modal analgesia regimen drugs * Use of serotonergic drugs, monoamine oxidase inhibitors (MAOI), mixed agonist/antagonist opioid analgesics
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Glenn Tan, M.D. — Cedars-Sinai Medical Center
- Study coordinator: Glenn Tan
- Email: glenn.tan@cshs.org
- Phone: 3104235841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.