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Opioid-Free Anesthesia Versus Opioid Based Anesthesia For Adolescent Idiopathic Scoliosis

RecruitingPhase 4Ages 8 Years - 18 YearsAllNashwa Ahmed
NCT07389096 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 ฮฑ2-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

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๐Ÿ“‹ Eligibility rules (as published)
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:โ€ข 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 โ‰ฅ 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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What it tests

  • Dexmedetomidine
  • Fentanyl (IV)
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Where

1 site
Port said university
Port Said, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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