Comparison of Norepinephrine vs Phenylephrine boluses for the treatment of hypotension during spinal anaesthesia in patients undergoing Caeserean section.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare number of boluses of norepinephrine vs. phenylephrine required to maintain maternal blood pressure when used to treat post-spinal hypotension in patients undergoing caesarean section.
研究概览
简要总结
Background and Aims: Hypotension following spinal anaesthesia for caesarean section is
common in spite of adequate fluid loading. Phenylephrine is the recommended drug to treat spinal
hypotension during caesarean section. Recently, norepinephrine boluses are being suggested as
an alternative to phenylephrine boluses. The aim of our study was to compare the effectiveness
of bolus doses of norepinephrine with phenylephrine to treat spinal hypotension during caesarean
section. Methods: Fifty patients undergoing elective caesarean section under spinal anaesthesia
were randomly assigned into two groups. Group P patients received phenylephrine 50 μg as an
intravenous bolus and group N received 4 μg of norepinephrine as intravenous bolus to treat
spinal hypotension. The primary objective of our study was to compare the number of bolus
doses of norepinephrine or phenylephrine required to treat spinal hypotension. The secondary
objectives were to compare the incidence of bradycardia, hypertension, nausea and vomiting in
mother and foetal outcomes. Results: The number of boluses of vasopressors required to treat
hypotension was significantly lower in group N (1.40 ± 0.577 vs. 2.28 ± 1.061, P = 0.001). The
frequency of bradycardia was high in group P, but this difference was not statistically significant
(4%vs. 20%, P = 0.192). Maternal complications such as nausea and vomiting and shivering were
comparable between the groups. The foetal parameters were also comparable between the two
groups. Conclusion: Intermittent boluses of norepinephrine are effective in the management of
spinal‑induced hypotension during caesarean section. The neonatal outcomes were similar in both
the groups. Norepinephrine boluses can be considered as an alternative to phenylephrine boluses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and 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
- •Elective CS under spinal anaesthesia, Normal singleton pregnancy beyond 36 weeks gestation, ASA physical status 1 or 2, Weight 50-100 kg, Height 150-180 cm.
排除标准
- •Allergy or hypersensitivity to phenylephrine or norepinephrine, Any hypertensive disorders of pregnancy, Cardiovascular or cerebrovascular disease, Fetal abnormalities.
结局指标
主要结局
To compare number of boluses of norepinephrine vs. phenylephrine required to maintain maternal blood pressure when used to treat post-spinal hypotension in patients undergoing caesarean section.
时间窗: end of surgery
次要结局
- To compare the effects of these two drugs on incidence of bradycardia, hypertension, nausea& vomiting in mother and foetal outcomes such as APGAR score & umbilical vein blood gases.(end of surgery)