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临床试验/NCT02149628
NCT02149628已完成4 期

The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide in Patients Undergoing Laparoscopic Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation

研究概览

简要总结

Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and trendelenburg position which result in oxidative stress and inflammatory response.

Propofol is well known to reduce those responses during anesthesia. Therefore, we try to figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and increase the nitric oxide activity during robot-LRP compared to that of desflurane.

To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric oxide will be measured as well.

Secondarily, kidney protection effect of propofol over desflurane will be compared.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia

排除标准

  • chronic renal failure ( estimated glomerular filtration rate <60 mL/min/1.73m2)
  • allergy to propofol, nuts
  • on diuretics, vitamin C or vitamin E within 5 days before surgery
  • Body mass index > 30 kg/m2
  • older than 70 years
  • who cannot read the patient consent form

研究组 & 干预措施

desflurane

Active Comparator

use desflurane as a primary anesthetics during anesthesia guided by bispectral index (BIS)

干预措施: Desflurane (Drug)

propofol

Experimental

propofol infusion with target-controlled infusion(TCI) device guided by BIS

干预措施: propofol (Drug)

结局指标

主要结局

changes of serum malondialdehyde, Interleukin-1β, interleukin-6, tumor necrotic factor-α, nitric oxide during operation

时间窗: 100 min after pneumoperitoneum, 10 min after decompression

次要结局

  • kidney function after anesthesia(1 day after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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