Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593836
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Olive oil


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Peristaltic grade [ Time Frame: 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 :
  1. Pylorus contraction ratio [ Time Frame: 3 mins ]
    Contraction ratio (%)= [(maximal pyloric ring diameter - minimal pyloric ring diameter)/minimal pyloric ring diameter] x 100

  2. Pylorus opening ratio: maximum and minimum [ Time Frame: 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

  3. Adverse effect of patients [ Time Frame: 48 hours ]
    record all adverse effect after study, include abdominal pain, heart burn, headache, allergy, etc.

  4. VAS score of patient about procedure [ Time Frame: 10 mins ]
    VAS score 1-10 about the painful sensation of patient during procedure

  5. Satisfaction of endoscopist [ Time Frame: 10 mins ]
    Four score was evaluated: very easy, easy, slightly difficult and difficult about the procedure due to gastric spasm


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593836


Contacts
Layout table for location contacts
Contact: Ming-Chih Hou, MD 886-2-28712121 ext 1320 mchou@vghtpe.gov.tw

Locations
Layout table for location information
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Ming-Chih Hou, MD    886-2-28712121 ext 1320    mchou@vghtpe.gov.tw   
Contact: Han-Chieh Lin, MD    886-2-28712121 ext 7506    hclin@vghtpe.gov.tw   
Principal Investigator: Ming-Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Layout table for investigator information
Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04593836    
Other Study ID Numbers: V101A-002
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Upper gastrointestinal endoscopy
Peppermint oil
L-menthol
Elderly
Additional relevant MeSH terms:
Layout table for MeSH terms
Peppermint oil
Menthol
Antipruritics
Dermatologic Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics