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临床试验/NCT06290583
NCT06290583已完成不适用

Comparison Between the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section

South Valley University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月21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
入组人数
120
试验地点
1
主要终点
Maternal arterial blood pressure

研究概览

简要总结

one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant >36 weeks singleton baby
  • American Society of Anesthesiologists (ASA) physical status 2
  • Age : between 18 years old and 35 years old

排除标准

  • Pregnant women with cardiac disease and history of psychiatric illness
  • Pregnant women who received spinal anesthesia and converted to general anesthesia
  • Women who have sensitivity to local anesthetics,
  • Women who have Eclampsia, abruption placenta or placenta previa
  • Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia

研究组 & 干预措施

Group B

Active Comparator

Patients will be given spinal anesthesia with bupivacaine (10 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected.

干预措施: Bupivacaine (Drug)

Group P

Active Comparator

Patients will be given spinal anesthesia with prilocaine (50 mg) added to morphine (100 microgram) and will be diluted with 0.9% saline to the 3 ml final volume to be injected.

干预措施: Prilocaine (Drug)

结局指标

主要结局

Maternal arterial blood pressure

时间窗: at base line before induction and every 3 minute during the first 15 min after spinal then every 5 mins until the end of surgery and every 1 hour postoperatively for 6 hours

Noninvasive blood pressure will be measured at selected time frame.. Hypotension will be defined as a decrease of systolic blood pressure of at least 20% from baseline. Upon its occurrence, and/or appearance of nausea and dizziness, treatment will be immediately with ephedrine 5mg/ dose

次要结局

  • Evaluation of duration of motor block(will be assessed before skin incision and every 15 min intervals until the end of surgery and then at 30-min intervals until its complete regression)
  • Total dose of ephedrine(From beginning of administration of spinal anesthesia until complete regression of motor blockade)

研究者

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

Mohamed Gaber Ahmed

Lecturer in anesthesiology, intensive care and pain management

South Valley University

研究点 (1)

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