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临床试验/NCT01334424
NCT01334424Unknown不适用

Oxidative Stress in Robot-assisted Laparoscopic Radical Prostatectomy

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年12月最近更新:
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
40
试验地点
1
主要终点
Amount of Malondialdehyde in plasma

研究概览

简要总结

Gut hypoperfusion - reperfusion injury is an unavoidable event at the end of laparoscopic surgery. It produces oxidative stress (reactive oxygen species). Malondialdehyde have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. On the basis of this knowledge, the investigators hypothesized that propofol has preventive effect for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical prostatectomy.

详细描述

Increased intrabdominal pressure is associated with pneumoperitoneum for laparoscopic procedures and is one of the main factors in impairment of splanchnic perfusion by compressing vessels. An hypoperfusion - reperfusion human model is observed during and soon after laparoscopic surgery. After deflation of the abdomen, intrabdominal pressure and splanchnic blood flow normalize, representing reperfusion.

Reactive oxygen species is produced in metabolic and physiologic processes, and harmful oxidative reactions may occur in organisms that remove them via enzymatic and nonenzymatic antioxidative mechanisms.

Propofol (2, 6 - diisopropylphenol), a highly liposoluble anaesthetic, has a potent antioxidant activity against lipid peroxidation in both in vitron and in vivo studies. Propofol also attenuates ischemia - reperfusion induced lipid peroxidation in humans. On the basis of this knowledge, we hypothesized that propofol has preventive effect for gut hypoperfusion - reperfusion induced injury in robot-assisted laparoscopic radical prostatectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients receiving robot-assisted laparoscopic radical prostatectomy in ASA II-III physical status

排除标准

  • history of sepsis or shock, clinically relevant cardiopulmonary disease, persistent tobacco abuse, recent antioxidant or vasoconstrictor use

研究组 & 干预措施

no propofol

Placebo Comparator

induction anesthesia with midazolam 0.2 - 0.3 mg/kg

干预措施: propofol (Drug)

propofol induction

Experimental

induction anesthesia with propofol 2 - 2.5 mg/kg

干预措施: propofol (Drug)

propofol maintenance

Experimental

induction anesthesia with midazolam 0.2 - 0.3 mg/kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)

干预措施: propofol (Drug)

propofol induction and maintenance

Experimental

induction anesthesia with propofol 2 - 2.5 mg/ kg and maintain anesthesia with propofol 2 mg/kg.h (maintenance dose)

干预措施: propofol (Drug)

结局指标

主要结局

Amount of Malondialdehyde in plasma

时间窗: one day

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other

研究点 (1)

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