Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Incidence of Shivering
研究概览
简要总结
Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption
详细描述
Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering.
Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.
We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
triple blinded
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance.,Aged between 21-40 years old, BMI: 18- 30 kg/m2, ASA: I and II., Scheduled for elective cesarean section under spinal anesthesia.
排除标准
- •History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus
研究组 & 干预措施
Group Cl (clonidine group)
will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia
干预措施: Clonidine Injection (Drug)
Group G (granisetron group)
will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia.
干预措施: Granisetron Injection (Drug)
Group C (control group)
will be given intravenous10ml normal saline 20 minutes before spinal anesthesia
干预措施: Normal Saline 10 mL Injection (Drug)
结局指标
主要结局
Incidence of Shivering
时间窗: Procedure (through out the period of spinal anesthesia)
• Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body
次要结局
- maternal blood presure(Procedure (preoperative as base and through out the period of spinal anesthesia))
- baby APGAR score(1 minutes and 5 minutes post natal)
- core body temperature(Procedure (preoperative as base and through out the period of spinal anesthesia))
- Maternal Heart rate(Procedure (preoperative as base and through out the period of spinal anesthesia))
研究者
Heba M Fathi
Ass. Professor
Zagazig University