Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

Phase 2

Completed

• Conditions: Spinal Curvatures
• Interventions: Drug: Group A amantadine sulfate; Other: Group B ringer lactate

• Registration Number: NCT03178708
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-03
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Study Start: 2017-08-01
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Being candidate for spine deformity correction surgery(scoliosis and kyphosis )
2. Willing to participate in the study

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Exclusion Criteria

1. Patient refusal
2. Patients with chronic kidney, lungs,Gastrointestinal tract, liver, or cardiovascular diseases.
3. Pregnant or breastfeeding women.
4. Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine,antipsychotic medications)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A amantadine sulfate	Group A amantadine sulfate	the patients will receive amantadine sulfate infusion using the dose 200 mg slowly I.V 3 hours prior to the surgery
Group B ringer lactate	Group B ringer lactate	the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.

Primary Outcome Measures

Name	Time	Method
postoperative opioid consumption	24 hours postoperative

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt