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

NCT ID: NCT04593836

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2020-12-31

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.

Conditions

Upper Gastrointestinal Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

L-menthol

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

Group Type: EXPERIMENTAL

L-menthol

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

L-menthol

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Peppermint oil; Olive oil

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Chih Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Chih Hou, MD

Role: CONTACT

mchou@vghtpe.gov.tw

886-2-28712121 ext. 1320

Facility Contacts

Ming-Chih Hou, MD

Role: primary

mchou@vghtpe.gov.tw

886-2-28712121 ext. 1320

Han-Chieh Lin, MD

Role: backup

hclin@vghtpe.gov.tw

886-2-28712121 ext. 7506

References

Yang TC, Chen PH, Hou MC, Peng LN, Lin MH, Chen LK, Huang YH. Antiperistaltic effect and safety of L-menthol for esophagogastroduodenoscopy in the elderly with contraindication to hyoscine-N-butylbromide. Sci Rep. 2022 Jun 21;12(1):10418. doi: 10.1038/s41598-022-14693-x.

Reference Type: DERIVED

PMID: 35729250 (View on PubMed)

Other Identifiers

V101A-002

Identifier Type: -

Identifier Source: org_study_id