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临床试验/NCT03406676
NCT03406676Unknown不适用

The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation

Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年8月1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
发起方
入组人数
70
试验地点
1
主要终点
Peripheral vascular resistance

研究概览

简要总结

To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.

详细描述

Hemodynamic characteristics of patients with obstructive jaundice are high cardiac output, low peripheral vascular resistance. The molecular basis for this feature is the increased production of NO. Methylene blue can increase peripheral resistance, the mechanism is: methylene blue is an oxidoreductase inhibitor, can inhibit the increased production of NO in the vascular endothelium, thereby increasing peripheral vascular resistance.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18-60 years;
  • American Society of Anesthesiologists(ASA) grade I~III;
  • TBIL>ULN and TBA>ULN; The patients with obstructive jaundice.

排除标准

  • Organs dysfunction(heart,lungs and etc);
  • Mental disorders;
  • in other clinical trial.

研究组 & 干预措施

Methylene blue

Experimental

2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.

干预措施: Methylene Blue (Drug)

结局指标

主要结局

Peripheral vascular resistance

时间窗: through operation completion, an average of 6 hours

the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 \~ 1200dyns / cm5)

次要结局

未报告次要终点

研究者

发起方
Southwest Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuguo Zheng, MD

Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Southwest Hospital, China

研究点 (1)

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