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临床试验/NCT04593836
NCT04593836Unknown3 期

Antiperistaltic Effect and Safety of L-menthol and Placebo for Upper GI Endoscopy in the Elderly With Contraindication to Buscopan: a Prospective, Randomized, Double-blind Study

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
60
试验地点
1
主要终点
Peristaltic grade

研究概览

简要总结

antiperistaltic effect and safety of L-menthol versus placebo for upper GI endoscopy in elderly patient with contraindication to Buscopan: randomized study

详细描述

Endoscopy is a important tool for diagnosis and treatment of gastrointestinal diseases. Effective inhibition of gastrointestinal motility during examination is important to achieve good results and quality.

Traditionally, hyoscine-N-butylbromide (Buscopan) is the most commonly used drugs that inhibit intestinal peristalsis. But the side effects of drugs were mentioned in many studies, such as arrhythmia, increased glaucoma, dysuria in patients who have benign prostatic hypertrophy and allergic reactions, and may even cause anaphylactic shock. Peppermint oil is the extract of the natural plant (Mentha X piperita L) which was growth in North America and Europe. L-menthol is main component of peppermint oil. In animal experiments, peppermint oil had effect of calcium channel blockers and cause gastrointestinal smooth muscle relaxing effect. Clinically, peppermint oil preparations were used to relieve stress headache, non-ulcer dyspepsia and irritable bowel syndrome. The oral or intestinal local spraying of peppermint oil or L-menthol showed inhibition of intestinal peristalsis in many studies, and improved colonoscopy, barium enema, retrograde cholangiography , and upper gastrointestinal endoscopy examination.

With the aging of the population of Taiwan and the universality of endoscopy for elderly patients, the safety of endoscopy in elderly patients has more and more attention. According to ASGA guidelines, age is not a contraindication for endoscopy. But 50% of elderly patients have contraindications for hyoscine-N-butylbromide use. Therefore, effort to find alternative medicine to improve quality of endoscopy in elderly patients is necessary. Therefore, the investigators design a research for comparing effect and safety of L-menthol and placebo in elderly patients who have contraindication of hyoscine-N-butylbromide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • >65 years old
  • routine endoscopic examination
  • Contraindication to Buscopan(such as arrhythmia, glaucoma, benign prostatic hyperplasia, ischemic heart disease...)

排除标准

  • Status post gastric or duodenal surgery
  • The patient with critical illness are not suitable for the endoscopic examination
  • Upper gastrointestinal bleeding
  • Gastric tumor
  • Gastric or duodenal ulcers are larger than 2 cm
  • Severe pyloric obstruction or deformity
  • Cancer patients received chemotherapy or radiation therapy
  • Had peppermint allergy

研究组 & 干预措施

L-menthol

Experimental

20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis

干预措施: L-menthol (Drug)

Placebo

Placebo Comparator

20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis

干预措施: Placebo (Drug)

结局指标

主要结局

Peristaltic grade

时间窗: 10 mins

Grade 1: no peristalsis; grade 2: mild peristalsis; grade 3: moderate peristalsis; grade 4: vigorous peristalsis; grade 5: markedly vigorous peristalsis.

次要结局

  • Pylorus contraction ratio(3 mins)
  • Pylorus opening ratio: maximum and minimum(3 mins)
  • Adverse effect of patients(48 hours)
  • VAS score of patient about procedure(10 mins)
  • Satisfaction of endoscopist(10 mins)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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