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

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04593836

Collaborator

(none)

Enrollment

Location

Arms

105

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Upper Gastrointestinal Endoscopy	Drug: L-menthol Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Peristaltic grade [10 mins]
Grade 1: no peristalsis; grade 2: mild peristalsis; grade 3: moderate peristalsis; grade 4: vigorous peristalsis; grade 5: markedly vigorous peristalsis.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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