Antiperistaltic Effect and Safety of L-menthol in the Elderly With Contraindication to Buscopan

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

Detailed Description
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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.

Official Title
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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

Conditions
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Upper Gastrointestinal Endoscopy

Intervention / Treatment
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* Drug: L-menthol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >65 years old routine endoscopic examination Contraindication to Buscopan(such as arrhythmia, glaucoma, benign prostatic hyperplasia, ischemic heart disease...) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-menthol<br>20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis | Drug: L-menthol<br>* 20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis<br>* Other names: Peppermint oil;|
| Placebo Comparator: Placebo<br>20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis | Drug: Placebo<br>* 20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis<br>* Other names: Olive oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristaltic grade | Grade 1: no peristalsis; grade 2: mild peristalsis; grade 3: moderate peristalsis; grade 4: vigorous peristalsis; grade 5: markedly vigorous peristalsis. | 10 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pylorus contraction ratio | Contraction ratio (%)= [(maximal pyloric ring diameter - minimal pyloric ring diameter)/minimal pyloric ring diameter] x 100 | 3 mins | 
| Pylorus opening ratio: maximum and minimum | Opening ratio (%) = [(pyloric ring diameter after administration of the antispasmodic agent - pyloric ring diameter before administration of the antispasmodic agent) / pyloric ring diameter before administration of the antispasmodic agent] x 100 | 3 mins | 
| Adverse effect of patients | record all adverse effect after study, include abdominal pain, heart burn, headache, allergy, etc. | 48 hours | 
| VAS score of patient about procedure | VAS score 1-10 about the painful sensation of patient during procedure | 10 mins | 
| Satisfaction of endoscopist | Four score was evaluated: very easy, easy, slightly difficult and difficult about the procedure due to gastric spasm | 10 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper gastrointestinal endoscopy, Peppermint oil, L-menthol, Elderly