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临床试验/NCT03810547
NCT03810547已完成不适用

A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1月30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
200
试验地点
1
主要终点
Change in Pain sensation: Visual analogue scale

研究概览

简要总结

100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia

详细描述

200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients between 18-55 years
  • ASA I and II

排除标准

  • BMI more than 35 years
  • Contraindications for regional anesthesia

研究组 & 干预措施

Spinal anesthesia

Active Comparator

Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia.

干预措施: Propofol 10 Mg/mL Intravenous Emulsion (Drug)

结局指标

主要结局

Change in Pain sensation: Visual analogue scale

时间窗: pain assessment during the operation and every 4 hours for 12 hours

Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt

Patients satisfaction: Satisfaction score changes

时间窗: Intraoperative assessment every 30 minutes till end of surgery.

Satisfaction score with maximum score is fully satisfied and least is completely disagree

次要结局

未报告次要终点

研究者

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

Ayman Anis Metry

Assistant professor

Ain Shams University

研究点 (1)

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