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临床试验/NCT04005664
NCT04005664已完成不适用

Prophylactic Phenylephrine and Fluid Co-administration to Reduce Spinal Hypotension During Elective Caesarean Section in a Resource-limited Setting: a Prospective Alternating Intervention Study

University of KwaZulu1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Post spinal hypotension

研究概览

简要总结

This single centre prospective alternating intervention study will aim to compare prophylactic phenylephrine given in the first litre of Ringers lactate as co-load in healthy patients having an elective caesarean section under spinal anaesthesia at Edendale Hospital to the existing national protocol guideline - for the treatment of obstetric spinal hypotension.

详细描述

Spinal anaesthesia is currently standard of care for patients undergoing caesarean section. Obstetric spinal hypotension is a common and important problem, related to important maternal and foetal outcomes. The prevention and treatment of spinal hypotension has been well researched in resource-rich settings, a context different from that encountered in the South African setting. It has been previously shown that a prophylactic phenylephrine infusion is effective in resource-limited settings, but this method is still dependent on the availability of an infusion pump.The ideal dose offering the best risk to benefit profile is 25 to 50 mcg/min. It has recently been shown that a prophylactic phenylephrine infusion, administered by an infusion pump, appears safe and effective in resource-constrained environments. However, some institutions in South Africa are limited by a lack of available infusion pumps. There is an urgent need to translate these research findings into a pragmatic management strategy that is safe and effective where this equipment is lacking. A 18g Jelco allows flow of approximately 100 ml/min in the absence of a pressure bag: therefore with 500 mcg in 1000 ml of ringers lactate and a fully opened line, a maximum dose of 50 mcg.min-1 will be achieved. If the rate is 50 ml/min (20 minutes for the first litre) the dose will be 25 mcg.min-1. This dose range will offer maximum benefit with low risk of side effects.

This exploratory study will establish if a phenylephrine (500 mcg) bolus, added to the first litre of Ringers lactate given as a co-load, is an effective and safe means to prevent post obstetric spinal hypotension. This regime will be compared to the existing South African national protocol of the management of obstetric spinal hypotension. The findings of this study will provide valuable information regarding a safe and potentially effective means to prevent obstetric spinal hypotension.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • All ASA 1-2 patients undergoing elective caesarean

排除标准

  • ASA grade >2 Hypertensive disease in pregnancy Dysrhythmia Failed spinal requiring conversion to a general anaesthetic

研究组 & 干预措施

Phenylephrine coload group

Active Comparator

Phenylephrine 500ug will be added to the first litre of ringer's lactate infused on initiation of spinal anaesthesia. If the phenylephrine infusion protocol is being used, and the mean arterial pressure (MAP) rises to greater than 20% of the initial MAP, and where this rise in MAP is not due to a recent bolus of either phenylephrine or ephedrine (within 2 minutes), the Ringers Lactate infusion will be switched off. The pharmacological management of hypotension, once diagnosed, will be the same regardless of the protocol being used. If the heart rate is greater than 70 beats per minute, phenylephrine will be administered in a dose of 50-100 mcg as an intravenous bolus. If the heart rate is less than 70 beats per minute, ephedrine will be administered in a dose of 5-10 mg. In both arms, Ringers Lactate fluid should run fast if hypotension occurs.

干预措施: Phenylephrine (Drug)

结局指标

主要结局

Post spinal hypotension

时间窗: from insertion of spinal anaesthesia until the delivery of the baby

The incidence of post spinal hypotension (SBP \<90 mmHg)

次要结局

  • Maternal symptoms(time of spinal insertion till delivery of the baby)
  • Highest blood pressure(time of spinal insertion till delivery of the baby)
  • Maternal cardiac arrest(time of spinal insertion till delivery of the baby)
  • Maternal bradycardia(time of spinal insertion till delivery of the baby)
  • Lowest blood pressure(time of spinal insertion till delivery of the baby)
  • Lowest maternal heart rate(time of spinal insertion till delivery of the baby)
  • Requirement for vasopressor(time of spinal insertion till delivery of the baby)

研究者

发起方
University of KwaZulu
申办方类型
Other
责任方
Sponsor

研究点 (1)

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