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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04593836
Acronym
Non-Buscopan
Enrollment
60
Registered
2020-10-20
Start date
2012-03-31
Completion date
2020-12-31
Last updated
2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Gastrointestinal Endoscopy

Keywords

Upper gastrointestinal endoscopy, Peppermint oil, L-menthol, Elderly

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.

Interventions

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

DRUGPlacebo

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

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peristaltic grade10 minsGrade 1: no peristalsis; grade 2: mild peristalsis; grade 3: moderate peristalsis; grade 4: vigorous peristalsis; grade 5: markedly vigorous peristalsis.

Secondary

MeasureTime frameDescription
Pylorus contraction ratio3 minsContraction ratio (%)= \[(maximal pyloric ring diameter - minimal pyloric ring diameter)/minimal pyloric ring diameter\] x 100
Pylorus opening ratio: maximum and minimum3 minsOpening 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 patients48 hoursrecord all adverse effect after study, include abdominal pain, heart burn, headache, allergy, etc.
VAS score of patient about procedure10 minsVAS score 1-10 about the painful sensation of patient during procedure
Satisfaction of endoscopist10 minsFour score was evaluated: very easy, easy, slightly difficult and difficult about the procedure due to gastric spasm

Countries

Taiwan

Contacts

Primary ContactMing-Chih Hou, MD
mchou@vghtpe.gov.tw886-2-28712121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026