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

NCT07389096 · tracked via the Priya Life Science Egypt tracker

Sponsor

Nashwa Ahmed

Phase

Phase 4

Started

2026-01-30

Last updated

2026-02-05

Condition(s) studied

Opioid Free Anesthesia

Investigational drug(s) / intervention(s)

Dexmedetomidine →Fentanyl (IV) →

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

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

Study 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

Sex

ALL

Min age

8 Years

Max age

18 Years

Healthy volunteers

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

Primary outcome measure(s)

intraoperative analgesic effectiveness, Measured by Heart Rate — 2 hours
Changes in heart rate recorded at predefined intraoperative intervals to assess physiological response to analgesia.
intraoperative analgesic effectiveness, Measured by blood pressure — 2 hours
Changes in blood pressure recorded at predefined intraoperative intervals.

Trial sites (1)

Facility	City	Region	Status
Port said university	Port Said	Egypt	Recruiting

More Nashwa Ahmed trials in Egypt

Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries to Evaluate the Hemodynamic Stability and Onset and Duration of Motor Block of Using Intrathecal Dexmedetomidine and Fentanyl Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07389096 on ClinicalTrials.gov ↗ ← All trials in Egypt