跳至主要内容
临床试验/NCT00273130
NCT00273130终止2 期

Randomised Evaluation of Neuroendocrine Stress Response During Upper Gastrointestinal Endoscopy With Standard or Ultrathin Endoscope.

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 1999年3月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
60
试验地点
2
主要终点
tachycardia, ischaemia, level of stress response

研究概览

简要总结

Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups.

  1. transnasal gastroscopy with thin endoscope
  2. transoral with thin endoscope
  3. standard size trans-oral endoscopy Stress response parameters (epinephrine, nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were monitored.

详细描述

A substantial number of descriptive studies and clinical trials have made it evident that upper gastrointestinal endoscopy elicits cardiovascular and respiratory changes. Recent publications have indicated less marked cardiovascular changes when using thinner endoscopes or transnasal endoscopy .Hormonal stress response during upper gastrointestinal endoscopy has also been described, but never related to the different methods of upper gastrointestinal endoscopy. Furthermore the patient tolerance is markedly improved compared to the standard transoral route.

The aim of the present randomised study was to evaluate the ECG-, blood pressure- and pulse rate changes and the endocrine stress response (norepinephrine, epinephrine and cortisol) elicited by upper gastrointestinal endoscopy using a thin endoscope either transnasally or orally or a standard endoscope orally.

Method and material Sixty patients were included consecutively after written and informed consent and were all over 18 years. Patients receiving digitalis, ß-blocking agents or calcium antagonists were excluded, as well as patients receiving drugs for thyroid dysfunction or patients receiving steroids. Patients with known disease or trauma of the nasal cavity were not included.

Only intended diagnostic upper gastrointestinal endoscopies were included. The patients received standard medication during the endoscopy if required.

Immediately prior to the endoscopy each of the 60 patients chose an envelope with the allocation to one of three groups A) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced transnasally (T group), B) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced orally (O group) or C) Endoscopy with a standard gastroscope (6 mm Olympus GIF XV10) (S group). All patients received the same amount of a local anesthetic spray (Lidocaine 10 mg/dose, ASTRA Zeneca) (twice in each nostril and twice in the oropharynx, given by one of two particular persons to ensure application of comparable doses of local anesthetic).

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
None

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

  • diagnostic gastroscopy, age over 18, danish speaking,

排除标准

  • use of beta blocking or any other heart rate modulating drug, antithyroid drugs

结局指标

主要结局

tachycardia, ischaemia, level of stress response

次要结局

  • acceptability of transnasal endoscopy

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验

Stress Response Using Thin and Standard Size... | 临床试验