Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Duration of sensory block
研究概览
简要总结
Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
详细描述
Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing lower limb orthopedic cancer surgery.
- •ASA I, II, III.
- •Age 20 to 70 year
- •Healthy volunteers
排除标准
- •Age less than 20 and older than
- •ASA IV, V.
- •patients' refusal.
- •patients with coagulopathy.
- •patients with severe valvular stenosis
- •patients with infection at site of injection
研究组 & 干预措施
Heavy Bupivacaine plus normal saline
2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline
干预措施: Bupivacain (Drug)
Heavy Bupivacaine plus dexmedetomidine
2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline
干预措施: Dexmedetomidine (Drug)
Heavy Bupivacaine plus dexmedetomidine
2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline
干预措施: Bupivacain (Drug)
Heavy Bupivacaine plus midazolam
2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline
干预措施: Midazolam (Drug)
Heavy Bupivacaine plus midazolam
2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline
干预措施: Bupivacain (Drug)
结局指标
主要结局
Duration of sensory block
时间窗: 12 hours
Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation
次要结局
- Sedation(12 hours)
- Incidence of vomiting occurrence(12 hours)
- Change in mean arterial blood pressure(12 hours)
- Duration of motor block(12 hours)
- Change in heart rate(12 hours)
研究者
Mohammed Said Nasef Zedan
assistant lecturer
National Cancer Institute, Egypt