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临床试验/NCT05810662
NCT05810662进行中(未招募)不适用

Randomized Study of Intraoperative Glucose Saline Versus Ringer Lactatein Cancer Pediatric Patients Doing Major Surgeries and Impact on Electrolytes ,Glucose and pH

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
PH and lactate level

研究概览

简要总结

To compare two electrolytes maintenance in perioperative period in children undergoing major surgeries on perioperative change in pH,lactate,sodium and glucose level

详细描述

Patients were randomized into 2 groups ringer lactate versus 5%dextrose in 0.9% saline,using a computer generated random list in blocks of 4 after recruitment the enrolling investigators opened sealed opaque envelopes that concealed group allocation participants ,trial investigators,attending anesthetist providing general anesthesia for the cases and the outcomes were blinded to group allocation

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
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1to 10 years Children undergoing major surgeries ie considered major if any invasive procedure in which extensive resection will be preformed e.g body cavity is opened,organs are removed and normal anatomy is altered abd duration not less than 2 hours or more than 5 hours.

排除标准

  • patient guardian refusal
  • _ Children with documented endocrine distrubances(DM,inborn error of metabolism,hyperthyroidism)
  • age less than one year
  • preexisting renal disease,hepatic disease and patien suffering from heart failure.
  • preexisting electrolyte imbalance (normal sodium level 135-145)

结局指标

主要结局

PH and lactate level

时间窗: In the introperative period

Three ABG will be collected from the patient. The first at start before any intervention,the second after start of replacement and the third at the end of the operation.

次要结局

  • Sodium and glucose level(The intraoperative period)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Mohammed Atteya

Anesthesia specialist

National Cancer Institute, Egypt

研究点 (1)

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