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

Upper Gastrointestinal Endoscopy Clinical Trial

— Non-Buscopan  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593836
• Other study ID #: V101A-002
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: December 2020

Study information

• Verified date: October 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ming-Chih Hou, MD
• Phone: 886-2-28712121
• Email: mchou[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Upper Gastrointestinal Endoscopy

Intervention

Drug:
• L-menthol
20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis
• Placebo
20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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