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临床试验/NCT00335010
NCT00335010已完成不适用

A Prospective Double Blinded Study on the Effect of Intravenously Administrated Nitroglycerine on Gastric Tissue Microvascular Bloodflow and Microvascular Hemoglobin Saturation During Gastric Tube Reconstruction

Erasmus Medical Center2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2005年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
differences in Microvascular bloodflow

研究概览

简要总结

The aim of the present study was to investigate if NTG, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage.

详细描述

Complications of oesophagectomy and gastric tube reconstruction are leakage and stenosis, which may be due to compromised microvascular blood flow (MBF) in the gastric tissue. We recently demonstrated that peri-operatively decreased MBF could be improved by topical administration of nitro-glycerine NTG). In this present study we investigate the effect of intravenous NTG on gastric microcirculation.

This single centre, prospective, double blinded study randomized thirty-two patients scheduled for esophagectomy into two groups. The intervention group received intravenous NTG during gastric tube reconstruction, as the control group received normal saline.

Baseline values of MBF, microvascular haemoglobin O2 saturation (μHbSO2), and microvascular haemoglobin concentration (μHbcon) were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck.

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

入排标准

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

入选标准

  • Planned esophagectomy with gastric tube reconstruction
  • written informed consent
  • ASA I and II

排除标准

  • younger than 18

结局指标

主要结局

differences in Microvascular bloodflow

differences in microvascular hemoglobinsaturation

次要结局

  • differences in anastomotic leakage
  • differences in anastomotic stenosis

研究者

申办方类型
Other

研究点 (2)

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