Low dose phenylephrine infusion for post spinal shivering in elective caesarean deliveries: A randomized controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Decreased incidence of shivering after spinal anaesthesia intraoperatively
研究概览
简要总结
Shivering after spinal anaesthesia is a common complication. This leads to redistribution of central heat to the periphery and overall heat loss. Shivering increases oxygen consumption, metabolic rate, carbon dioxide production, lactic acidosis. Also it interferes with electrocardiography, blood pressure, oxygen saturation
monitoring and has its detrimental effects on wound healing and coagulation. Phenylephrine being a alpha-1 adrenergic receptor agonist, due to its peripheral vasoconstrictive effect, the core to peripheral redistribution of blood volume is minimal, which may maintainthe core body temperature and reduce shivering during
spinal andestnesia.
Aim: Low dose phenylephrine infusion after spinal anesthesia may decrease incidence of shivering in caesarean sections.
Objectives:
1.To evaluate the effect of phenylephrine infusion on incidence of shivering.
2.To evaluate the effect of phenylephrine infusion on
- Severity of shivering.
- Intraoperative core body temperature.
- Intraoperative hypotension.
Materials and methods: A prospective randomized controlled trial
Sample size: 45 in each group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women aged between 18 to 40 years, belonging to ASA-PS II undergoing elective caesarean section under spinal anaesthesia.
排除标准
- •1.Preoperative hyperthermia (more than 38 degree Celsius) or hypothermia ( less than 36 degree Celsius)
- •BMI more than 30 kg per metre square
- •Patients with history of bradycardia, severe cardiac dysfunction, heart failure, pulmonary arterial hypertension
- •Patients with ear disease
- •Surgical time more 2 hours
- •Intraoperative blood transfusion
- •Patients with diabetes mellitus, pregnancy induced hypertension, hypothyroid or hyperthyroid, anemia.
结局指标
主要结局
Decreased incidence of shivering after spinal anaesthesia intraoperatively
时间窗: -Preoperatively | -Immediately after spinal anaesthesia | -Every 10 min till 120 min
次要结局
- 1. Decreased change in core body temperature intraoperatively and postoperatively(2. Decreased incidence of hypotension intraoperatively, nausea and vomiting postoperatively)
研究者
Renuka
Karnataka institute of medical sciences hubballi