Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Spinal Curvatures

Treatments: Drug: Group A amantadine sulfate; Other: Group B ringer lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT03178708

IV amantadine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Group A amantadine sulfate

Active Comparator group

Description:

the patients will receive amantadine sulfate infusion using the dose 200 mg slowly I.V 3 hours prior to the surgery

Treatment:

Drug: Group A amantadine sulfate

Group B ringer lactate

Placebo Comparator group

Description:

the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.

Treatment:

Other: Group B ringer lactate