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临床试验/NCT04695613
NCT04695613已完成3 期

Amino Acids Versus Magnesium Sulphate Infusion in Controlling Postoperative Shivering

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Postoperative shivering grade

研究概览

简要总结

Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery under general anesthesia.

详细描述

A written informed consent was taken from the patients. Patients were assigned randomly to two groups (40 subjects each) to be anesthetized and infused with either an iv amino acid starting just before and during anesthesia (group A) or an iv magnesium sulphate starting just before and during anesthesia (group M) in the perioperative period.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II who were listed for elective percutaneous nephrolithotomy PCNL surgery under general anesthesia.

排除标准

  • Hepatic inefficiency
  • Renal inefficiency
  • Spinal anesthesia because of a different mechanism of hypothermia

研究组 & 干预措施

aminoacid group

Active Comparator

patients received an IV amino acid infusion 150 ml/kg/hr starting just before and during anesthesia

干预措施: Aminoacid (Drug)

magnesium sulfate group

Active Comparator

patients received an IV magnesium sulphate bolus and infusion 40 mg/kg starting just before and during anesthesia

干预措施: Magnesium sulfate (Drug)

结局指标

主要结局

Postoperative shivering grade

时间窗: 2 hours postoperative

"grading of shivering," in which shivering degree was assessed as 1 of 5 levels (0, 1, 2, 3, and 4), grade 0 lack of shivering, grade 1 slight shivering (inconsiderable yet apparent peripheral vasoconstriction), grade 2 medium level shivering (muscular activity in one muscle group only) grade 3 severe shivering (muscular activity in more than one muscle group without generalized shivering) and grade 4 generalized shivering.

次要结局

  • Shivering frequency(2 hours postoperative)
  • Blood loss volume(2 hours postoperative)

研究者

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

Omar Makram Soliman

lecturer of anesthesia

Assiut University

研究点 (1)

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