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临床试验/NCT04634981
NCT04634981已完成不适用

Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section: A Prospective Non-randomized Study Comparing Spinal Versus General Anesthesia

Benha University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
APGAR score

研究概览

简要总结

Spinal anesthesia (SA) has become the standard technique in elective cesarean section (CS) as it results in less maternal and neonatal morbidity than general anesthesia (GA) (Grade-A recommendation, NICE). For women requiring emergency CS, rapid sequence general anesthesia (RSGA) is commonly used because this technique is faster to perform than SA. Though several randomized trials have compared the maternal and fetal outcome between these two anesthetic techniques, the studies with respect to category 1 CS (emergent conditions that hold immediate threat to life of the woman or fetus) are limited.

详细描述

Full term pregnant females will be included in this study. They will be allocated into two groups:

(Group G): will receive rapid sequence general anesthesia, and (Group S): will receive spinal anesthesia. After preoperative assessment and investigations by the attending anesthesiologist, the decision of the anesthetic approach will be decided by the attending anesthesiologist according to indications for CS.

Before induction of anesthesia intravenous (IV) ranitidine 50 mg will be administered after establishing an IV access. On the operating table, vital signs will be monitored for all parturients throughout the surgery according to the standard departmental protocol.

fetal well being will be assessed after delivery by using 1 minute and 5 min APGAR score and umbilical cord PH . in addition to maternal vital signs intra-operative then follow up any complications that may occur to the mother post-operative.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

APGAR score

时间窗: 5 minutes after delivery

Apgar score is a method for assessment of neonatal well-being after birth (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)

次要结局

  • Neonatal ICU admission(from delivery of the baby up to 24 hour postoperative)
  • Length of hospital stay(up to 1 month)
  • decision-to-delivery interval (DDI)(from decision to operate till delivery of the baby)
  • Umbilical cord PH(immediately after delivery)
  • Occurrence of maternal complications postoperative(from recovery from anesthesia up to 24 hours postoperative)

研究者

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

Samar Rafik Mohamed Amin

lecturer of anesthesia and surgical ICU

Benha University

研究点 (1)

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