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

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 3

Conditions: Upper Gastrointestinal Endoscopy

Treatments: Drug: Placebo; Drug: L-menthol

Study type: Interventional

Funder types: Other

Identifiers

NCT04593836

V101A-002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

L-menthol

Experimental group

Description:

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

Treatment:

Drug: L-menthol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo