A prospective, randomised controlled,comparative study of the effect of forced air warmer,Ondansetron or their combination on shivering during caesarean section under spinal anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Prevention of shivering during cesarean section under spinal anaesthesia
研究概览
简要总结
Shivering is the one of the most commonly observed complications in anesthesia practice. It has a very high incidence (60 %) in general anaesthesia, whereas the incidence in regional anaesthesia ranges between 40-60 %.In addition, perioperative shivering can occur in up to 85% of patients undergoing cesarean delivery under spinal anesthesia.Hypothermia during regional anesthesia is common and is a cause of shivering. There are three reasons for hypothermia under spinal anesthesia. First, spinal anesthesia leads to internal redistribution of heat from the core to the peripheral compartment . Secondly, with loss of thermoregulatory vasoconstriction below the level of the spinal block, there is increased heat loss from body surfaces. Lastly, there is altered thermoregulation under spinal anesthesia characterized by a 0.5oC decrease in vasoconstriction and shivering thresholds .However, redistribution can be prevented by cutaneous warming. Warming markedly increases peripheral tissue heat content and reduces the core-to-peripheral tissue temperature gradient , which affects temperature .Recently, it has been established that one of the various pathways involved in Post anesthesia shivering is through the 5-HT3 receptor, so 5-HT3 antagonist must have a role in prevention PAS.
After obtaining informed consent, 120 full term parturients women who are eligible to participate in the study will be be allocated randomly using closed envelope technique to one of three groups:Group O (n=40): will Receive Injection Ondensetron 4mg iv . just after giving block with no forced air warmingGroup W (n=40): will Receive upper body forced-air warming set at 42°c after giving block without Injection Ondensetron and warming device is continued till end of surgery.Group C (n=40): will recieve Injection Ondensetron 4mg (I.V. just after giving block) plus active forced-air warming after giving block to end of sugery.
we will monitor core temperature(tymphanic membrane) and skin temperature during surgery at regular intervals. Grades of shivering will also be noted and compared between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •American Society of Anesthesiologists (ASA) physical Status I and II full-term parturients, 18–35 years old, scheduled for elective lower segment cesarean section surgery under spinal anesthesia will be enrolled in this study.
排除标准
- •Pregnant women having contraindication to spinal anesthesia, those who have accompanying gestational hypertension, placenta previa, and twin pregnancy, those whose weight will be < 50 kg or > 100 kg,those with cardiopulmonary disease, psychological disorder, and thyroid disorders,those with a recent history of any drugs usage except vitamins and minerals,patients who are likely to receive blood transfusion intraoperatively and with body temperature more than 38°C or <36.5°C will be excluded from the study.
结局指标
主要结局
Prevention of shivering during cesarean section under spinal anaesthesia
时间窗: Preoperatively before entering OT,after entering OT,after administration of Subarachnoid block,at every 5 min interval for first 15min,then at every 15 min interval till the end of surgery
次要结局
- Incidence of hypothermia,nausea and vomiting.(Preoperatively before entering OT,after entering OT,after administration of Subarachnoid block,at every 5 min interval for first 15min,then at every 15 min interval till the end of surgery)