Clinical trial NCT04593836: Antiperistaltic Effect and Safety of L-menthol in the Elderly With Contraindication to 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Upper Gastrointestinal Endoscopy
Keywords: Upper gastrointestinal endoscopy
Peppermint oil
L-menthol
Elderly
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Peristaltic grade
timeFrame: 10 mins
Secondary outcomes:
measure: Pylorus contraction ratio
timeFrame: 3 mins
measure: Pylorus opening ratio: maximum and minimum
timeFrame: 3 mins
measure: Adverse effect of patients
timeFrame: 48 hours
measure: VAS score of patient about procedure
timeFrame: 10 mins
measure: Satisfaction of endoscopist
timeFrame: 10 mins
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ming-Chih Hou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.