Opioid-free versus opioid-based anesthesia for adolescent idiopathic scoliosis
Official title: Opioid-Free Anesthesia Versus Opioid Based Anesthesia For Adolescent Idiopathic Scoliosis A Prospective Randomized Double-Blind Controlled Trial
Run by Port Said University hospital · NCT07389096 · Data updated 2026-11-12
This test uses dexmedetomidine instead of intraoperative opioids to see if adolescents having scoliosis surgery have better pain control and fewer complications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Port Said University hospital Academic / other |
| Locations | 1 site (Port Said) |
| Status | Recruiting |
| Started | January 30, 2026 |
| Main results expected | January 30, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07389096 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents under 18 with adolescent idiopathic scoliosis who are ASA I–II, not on regular opioids, and scheduled for corrective spinal fusion at the enrolling center.
✕Probably not a fit
Patients with non-idiopathic or neuromuscular scoliosis, significant cardiac/respiratory/hepatic/renal disease, chronic opioid use, or those who cannot tolerate dexmedetomidine (severe bradycardia/arrhythmia) are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, parallel-group trial enrolling 30 adolescents with idiopathic scoliosis undergoing corrective spinal surgery. Patients are randomized to an opioid-free anesthesia approach using dexmedetomidine (1 μg/kg loading dose followed by 0.5 μg/kg/h infusion) versus a standard opioid-based regimen that includes fentanyl. The primary outcome is intraoperative analgesic effectiveness, with secondary outcomes including perioperative complications, need for rescue fentanyl, and surgeon satisfaction. Key eligibility criteria include age under 18 years and ASA physical status I–II, with multiple exclusions for neuromuscular disease, chronic opioid use, significant organ dysfunction, or contraindications to study drugs.
Why it matters
Potential benefit: If successful, this approach could reduce intraoperative and perioperative opioid exposure, lower opioid-related side effects, and improve recovery after scoliosis surgery in adolescents.
How similar studies have gone: A few small randomized trials in spinal surgery have reported reduced opioid requirements and improved analgesia with perioperative dexmedetomidine, but intraoperative opioid-free anesthesia with dexmedetomidine for scoliosis under general anesthesia remains relatively novel and under-studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:Patients younger than 18 years of age, classified as American Society of Anesthesiologists (ASA) Physical Status I or II, and will be scheduled for surgical correction of adolescent idiopathic scoliosis. \- Exclusion Criteria:• Refusal to participate in the study or to allow use of personal data * Non-idiopathic scoliosis * Contraindications to commonly used perioperative medications * ASA Physical Status ≥ III * Presence of neuromuscular disorders or severe cardiac dysfunction * Requirement for postoperative mechanical ventilation * Regular use of analgesics or opioids * History of allergy to opioids or dexmedetomidine * Diagnosed mental disorders * Severe hepatic or renal dysfunction * Coagulopathy or significant pulmonary disease * Preoperative or postoperative neurological deficits * Occurrence of serious arrhythmia, hypotension, or bradycardia necessitating discontinuation of dexmedetomidine infusion
Where it's running
-
Port said university
Port Said, Egypt Recruiting
Study contacts
- Study coordinator: Nashwa gomaa Ahmed, MD
- Email: dr_nashwa_2008@yahoo.com
- Phone: 00201005289328
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.