Opioid-free versus opioid-based anesthesia for adolescent idiopathic scoliosis

Opioid-Free Anesthesia Versus Opioid Based Anesthesia For Adolescent Idiopathic Scoliosis A Prospective Randomized Double-Blind Controlled Trial

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: PHASE4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 8 Years to 18 Years
• Sex: All
• Sponsor: Port Said University hospital (other)
• Locations: 1 site (Port Said)
• Trial ID: NCT07389096 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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.

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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 this trial is running

Port Said

• Port said university — Port Said, Egypt (RECRUITING)

Study contacts

• Study coordinator: Nashwa gomaa Ahmed, MD

Conditions: Opioid Free Anesthesia