Comparison of two doses of norepinephrine infusion for prophylaxis of maternal hypotension following spinal anaesthesia in pregnant women undergoing emergency c-section: a two arm, double blind randomised control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- To assess frequency of post-spinal hypotension, intra-operative bradycardia, intra-operative hypertension.
研究概览
简要总结
Maternal hypotension following spinal anaesthesia during caesarean section is a common occurrence. Norepinephrine infusion is being practiced for its prevention in elective caesarean section. Recently published study has established superiority of different doses for the same. But the superiority of doses is not yet well established for emergency caesarean section. To address this lacunae in the knowledge, we adopted a parallel arm, double blind, randomized controlled trial with the objective to estimate the incidence of maternal hypotension, intra-operative bradycardia and intra-operative hypertension among pregnant women undergoing emergency caesarean section under spinal anaesthesia. Our research hypothesis is to prove that the prophylactic infusion rate of 0.050 mcg/min/kg body weight is superior to infusion rate of 0.025 mcg/min/kg body weight in preventing maternal hypotension, intraoperative bradycardia, and intraoperative hypertension against the null hypothesis that former is not superior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Labouring and non-labouring pregnant women with period of gestation more than 37 weeks undergoing category II caesarean section.
- •Non-reassuring cardiotocography (CTG) including anyone of the following- Fetal heart rate(FHR) as per RCOG guidelines (FHR 100-109bpm or 161-180bpm).
- •Variability less than 5bpm for more than 40minutes but less than 90 minutes.
- •Early deceleration.
- •Variable deceleration.
- •Single prolonged deceleration less than 90 seconds.
排除标准
- •Complications such as hypertensive disorders of pregnancy, cardiovascular or cerebrovascular disease, multiple gestation, known fetal abnormality.
- •Hemodynamically unstable or baseline SBP less than 100 mmHg. ASA physical status 3 or more than
- •Severely compromised fetus who requires immediate administration of general anaesthesia.
- •Presence of contra-indications for spinal anaesthesia.
- •Participants who have received labour analgesia.
结局指标
主要结局
To assess frequency of post-spinal hypotension, intra-operative bradycardia, intra-operative hypertension.
时间窗: maternal heart rate and blood pressure will be taken at 2 minute interval from before intrathecal injection until the delivery of the fetus.
次要结局
- Presence of fetal acidosis(APGAR score)
研究者
Shivangi Maddheshiya
AIIMS PATNA