RecruitingPhase 4NCT07389096

Opioid-Free Anesthesia 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


Sponsor

Nashwa Ahmed

Enrollment

30 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Summary

Opioid-free anesthesia (OFA) is a multimodal analgesic approach designed to eliminate the intraoperative use of systemic, neuraxial, or intracavitary opioids. This technique employs a combination of antinociceptive agents targeting various pathways within the central and peripheral nervous systems to achieve effective analgesia. Dexmedetomidine (DEX), a highly selective α2-adrenoreceptor agonist, is a centrally acting non-opioid agent increasingly utilized in clinical practice for its antinociceptive and anxiolytic properties. Only a few prospective randomized controlled trials have specifically examined the postoperative analgesic efficacy of intraoperative dexmedetomidine infusion in patients undergoing spinal surgery, with limited data focusing on this as a primary endpoint. Importantly, no clinical studies have investigated its analgesic impact in patients undergoing spinal surgery under general anesthesia.


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria1

  • \-

Exclusion Criteria12

  • 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

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Interventions

DRUGDexmedetomidine

patients will Receive dexmedetomidine with a loading dose of 1 μg/kg followed by a maintenance infusion of 0.5 μg/kg/h.

DRUGFentanyl (IV)

patients will Receive fentanyl with a loading dose of 1 μg/kg followed by a maintenance infusion of 0.5 μg/kg/h.


Locations(1)

Port said university

Port Said, Egypt

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NCT07389096