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

ConditionOpioid Free Anesthesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age8-18
SponsorNashwa Ahmed

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Non-idiopathic scoliosis

Contraindications to commonly used perioperative medications

ASA Physical Status ≥ III

Presence of neuromuscular disorders or severe cardiac dysfunction

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    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)

    Drug

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group OFA (Opioid-Free Anesthesia):Active comparator 1 intervention
Group B: Group OBA (Opioid-Based Anesthesia)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

intraoperative analgesic effectiveness, Measured by Heart Rate

Changes in heart rate recorded at predefined intraoperative intervals to assess physiological response to analgesia.

Time frame
2 hours
2

intraoperative analgesic effectiveness, Measured by blood pressure

Changes in blood pressure recorded at predefined intraoperative intervals.

Time frame
2 hours

Secondary outcomes

1

the requirement for rescue fentanyl

Postoperative pain was assessed at 2, 6, 12, 24 hours using the Numerical Rating Scale (NRS).

Time frame
24 hour
2

surgeon satisfaction

using Likert scale, with scores ranging from 1 to 5,

Time frame
2 hours
3

Assessment of Intraoperative Blood Loss

evaluating the volume of blood collected in suction canisters, the degree of saturation of surgical gauze, and the visible blood within the operative field

Time frame
2 hours
4

hemodynamics

Heart rate (HR) and blood pressure (BP) were continuously monitored using non-invasive techniques at 30-minute intervals throughout the procedure.

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nashwa Ahmed

Lead sponsor

Port Said University hospital

Sponsor institution

Source ClinicalTrials.gov
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