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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative opioid consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being candidate for spine deformity correction surgery(scoliosis and kyphosis )
- •Willing to participate in the study
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Group A amantadine sulfate (Drug)
Group B ringer lactate
the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.
干预措施: Group B ringer lactate (Other)
结局指标
主要结局
postoperative opioid consumption
时间窗: 24 hours postoperative
次要结局
未报告次要终点
研究者
Ghada Mohammed AboelFadl
Principal Investigator
Assiut University