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

Phase 3

• Conditions: Upper Gastrointestinal Endoscopy
• Interventions: Drug: Placebo; Drug: L-menthol

• Registration Number: NCT04593836
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-10-22
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis
L-menthol	L-menthol	20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis

Primary Outcome Measures

Name	Time	Method
Peristaltic grade	10 mins	Grade 1: no peristalsis; grade 2: mild peristalsis; grade 3: moderate peristalsis; grade 4: vigorous peristalsis; grade 5: markedly vigorous peristalsis.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan