Impact of Sub-anaesthetic Dose of Ketamine Versus Ephedrine on Post Spinal Hypotension in Caesarean Delivery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of hypotension post spinal in CS
研究概览
简要总结
Comparing ketamine and ephedrine to decrease the incidence of post spinal hypotension after caesarean section delivery.
详细描述
To compare the effect of ketamine versus ephedrine in decreasing the incidence of hypotension in caesarean section delivery a study group including 50 participants will receive ketamine and 50 group will receive ephedrine after the consent and detailed history the two groups will receive preload of 500ml enter acetate then dormicum for sedation then spinal anesthesia will be performed initial blood pressure and heart rate will be measured then every five minutes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing Caesarian Section under spinal anesthesia,
- •Patients aged 18-45 years,
- •At term (≥37-week gestation),
- •American Society of Anaesthesiologists (ASA) physical status 1 or 2
排除标准
- •Pre-eclampsia,
- •Chronic hypertension, cardiovascular troubles,
- •Any contraindication to regional anesthesia such as local infection or bleeding disorders,
- •Any hypersensitivity to ketamine.
- •Declined informed consent.
- •American Society of Anaesthesiologists (ASA) physical status lll or lV
研究组 & 干预措施
Ephedrine group
15 mg ephedrine
干预措施: Ephedrine (Drug)
Ketamine group
0.5mg/kg ketamine
干预措施: Ketalar (Drug)
结局指标
主要结局
Incidence of hypotension post spinal in CS
时间窗: From injection till the end of surgery
For ketamine Group: women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline. ( Reves JG et al,2010 ) * For ephedrine Group: women receiving bolus of 15mg of ephedrine * All the patients will receive 2 mg midazolam IV directly after delivery of the fetus.( Perumal DK et al ) * Heart Rate (HR) and Mean Arterial Blood Pressure (MAP) will be recorded at baseline 5 minutes prior to the intrathecal injection and 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection and then every 15 minutes till the end of the operation. * Incidence of hypotension will be recorded which is defined as MAP less than 20% below the baseline or was ≤ 65 mmHg. Incidence of severe hypotension ≤ 50 mmHg will be recorded.
次要结局
未报告次要终点