Intravenous Dexmedetomidine Versus Midazolam in Preventing Shivering in Trauma Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Incidence of shivering
研究概览
简要总结
Shivering is a common and significant complication following spinal anesthesia, with a reported incidence of 40-60% especially in trauma patients due to pain, stress response, blood loss, and disrupted thermoregulation. Shivering increases oxygen demand, impairs monitoring, and reduces patient comfort. Effective pharmacologic prevention of shivering is crucial in this population.
Dexmedetomidine is a highly selective α2-adrenoreceptor agonist. It is widely used as an adjunct to general as well as regional anesthesia for better hemodynamic stability, sedation, and prolonged duration of regional anesthesia and is effective in reducing shivering by centrally modulating thermoregulation.
Midazolam, a GABA-A agonist, Intravenous midazolam premedication is commonly used for conscious sedation, anxiolysis, and amnesia with spinal anesthesia is also known to have anti-shivering properties attributed to its action on GABA-A receptors, promoting anxiolysis and possibly resetting the hypothalamic thermoregulatory threshold.
There are limited clinical data comparing the effect of intravenous dexmedetomidine and midazolam and its effect on shivering
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •: ASA I-II Adult trauma patients (age 18-60 years). Undergoing lower limb orthopedic surgery with tourniquet under spinal anesthesia
排除标准
- •- Allergy to study drugs. Severe cardiovascular, hepatic, or renal disease Hypovolemic shock. History of psychiatric illness or chronic sedative use. Bradycardia (<50 bpm), heart block, or uncontrolled hypotension. Febrile illness or use of active warming devices
研究组 & 干预措施
Group D
Patients will receive i. v. dexmedetomidine 0.5 μg.kg-1 post-spinal anesthesia
干预措施: Dexmedetomidine (Drug)
Group M
and patients will receive i.v. midazolam 0.05 mg.kg-1 post-spinal anesthesia
干预措施: Midazolam (Drug)
结局指标
主要结局
Incidence of shivering
时间窗: 1 hours postoperative
Incidence of shivering intraoperatively every 10 min and postoperatively every 15 min for 1 hour
次要结局
未报告次要终点
研究者
Mahmoud Mohamed Gad
residant doctor at Assiut university hospital
Assiut University