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临床试验/NCT03248817
NCT03248817Unknown4 期

Comparison of Different Protocols of Phenylephrine Infusion for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery

Cairo University1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2017年9月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
255
试验地点
1
主要终点
Incidence of Post-spinal anesthesia hypotension

研究概览

简要总结

the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine

详细描述

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Full term
  • Pregnant women
  • Scheduled for cesarean delivery

排除标准

  • Pre-eclampsia
  • Eclampsia
  • Hemorrhage
  • Cardiac dysfunction
  • Baseline low heart rate (below 60 bpm)

研究组 & 干预措施

single shot

Experimental

spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered

干预措施: single shot phenylephrine (Drug)

single shot

Experimental

spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered

干预措施: Bupivacaine (Drug)

fixed infusion

Active Comparator

spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred

干预措施: fixed infusion phenylephrine (Drug)

fixed infusion

Active Comparator

spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred

干预措施: Bupivacaine (Drug)

variable infusion

Active Comparator

spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure

干预措施: variable infusion phenylephrine (Drug)

variable infusion

Active Comparator

spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Incidence of Post-spinal anesthesia hypotension

时间窗: 30 minutes after spinal anesthesia

Defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.

次要结局

  • systolic blood pressure(2 hours after spinal anesthesia)
  • Incidence of severe Post-spinal anesthesia hypotension(30 minutes after spinal anesthesia)
  • APGAR score(10 minutes after delivery)
  • Incidence of reactive hypertension(2 hours after spinal anesthesia)
  • diastolic blood pressure(2 hours after subarachnoid block)
  • heart rate(2 hours after subarachnoid block)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Hasanin

Assistant professor

Cairo University

研究点 (1)

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