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

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

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

Study Overview

• Status: Unknown
• Conditions: Upper Gastrointestinal Endoscopy
• Intervention / Treatment: Drug: L-menthol; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: L-menthol; 20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis	Drug: L-menthol; 20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis; Other Names: Peppermint oil
PLACEBO_COMPARATOR: Placebo; 20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis	Drug: Placebo; 20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis; Other Names: Olive oil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Elderly; Upper gastrointestinal endoscopy; Peppermint oil; L-menthol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipruritics; Peppermint oil; Menthol
• Other Study ID Numbers: V101A-002