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临床试验/NCT07076654
NCT07076654已完成不适用

Effectiveness of Preoperative Oral Caffeine in Preventing Spinal-Induced Hypotension During Cesarean Delivery: A Double Blind Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月12日最近更新:
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
90
试验地点
1
主要终点
Incidence of spinal hypotension

研究概览

简要总结

Hypotension after spinal anesthesia is critical. Thus several interventions have been proposed to mitigate such effect.

详细描述

Hypotension is a critical issue related to spinal anesthesia during cesarean delivery. Researchers of this study aimed to evaluate the impact of preoperative oral caffeine on the incidence of spinal hypotension during cesarean delivery.

研究设计

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

入排标准

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

入选标准

  • full term pregnant
  • undergoing elective cesarean delivery

排除标准

  • patient refusal
  • baseline systolic pressure < 100 mmHg
  • contraindication to spinal anesthesia
  • allergy to caffeine

研究组 & 干预措施

Caffeine

Active Comparator

Patients will receive oral caffeine 200 mg before spinal anesthesia

干预措施: Caffeine (200 mg) (Drug)

Control group

Placebo Comparator

Will receive placebo before spinal anesthesia

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of spinal hypotension

时间窗: After spinal anesthesia till delivery

Decrease systolic blood pressure \< 20% of baseline value

次要结局

  • Time to first hypotensive episode(after induction of spinal anesthesia)
  • Incidence of severe hypotension(After onset of spinal anesthesia)
  • APGAR score(at 5 minutes after delivery)
  • Umbilical artery pH(At 5 minutes after delivery)

研究者

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

Mina Adolf Helmy

Lecturer of anesthesia and critical care

Cairo University

研究点 (1)

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