Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

Study Overview
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Brief Summary
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During the surgical procedure of scoliosis correction, large surgery extent and long-lasting strong nociceptive stimulation lead to postoperative pain formation of greater intensity compared with other orthopedic interventions. In these patients, duration of postoperative symptoms is longer, and may lead to persistent pain formation due to developing neuroplastic changes in the central nervous system.

Detailed Description
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Instrumentation in correction operations for spinal deformities as vertebral fusion, congenital and traumatic scoliosis, carries a 0.5-5% risk of injuring the spinal cord during spinal surgery. These complications are generally results of complex factors such as direct effects of compression on the spinal cord, distraction, the effects of spinal ischemia or arterial hypotension. The purpose of the wake-up test is to monitor voluntary motor function of the lower limbs once the vertebrae have been instrumented and distracted. The depth of anesthesia is gradually lightened up to the point where patients are able to respond to verbal commands. As the voluntary movement of lower extremities is demonstrated, the depth of anesthesia is increased to complete the surgery.

Official Title
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The Implications of Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients as Regard Its Effect on the Duration of Wake up Test and Postoperative Opioid Consumption

Conditions
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Spinal Curvatures

Intervention / Treatment
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* Drug: Group A amantadine sulfate
* Other: Group B ringer lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being candidate for spine deformity correction surgery(scoliosis and kyphosis ) Willing to participate in the study Exclusion Criteria: Patient refusal Patients with chronic kidney, lungs,Gastrointestinal tract, liver, or cardiovascular diseases. Pregnant or breastfeeding women. Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine,antipsychotic medications)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the role of preoperative administration of Amantadine Sulphate on the duration of wake up test and postoperative opiod consumption in patients undergoing major spine deformities corrective surgeries.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A amantadine sulfate<br>the patients will receive amantadine sulfate infusion using the dose 200 mg slowly I.V 3 hours prior to the surgery | Drug: Group A amantadine sulfate<br>* infusion solution for slowly intravenous application 3 hours preoperative<br>* Other names: PK-Merz Infusion amantadine sulfate;|
| Placebo Comparator: Group B ringer lactate<br>the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery. | Other: Group B ringer lactate<br>* infusion solution for intravenous application 3 hours preoperative<br>* Other names: Lactated ringer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative opioid consumption |  | 24 hours postoperative |