NCT04593836

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
7 years until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

8.8 years

First QC Date

October 22, 2013

Last Update Submit

October 13, 2020

Conditions

Upper Gastrointestinal Endoscopy

Keywords

Upper gastrointestinal endoscopyPeppermint oilL-mentholElderly

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pylorus contraction ratio

    3 mins

  • Pylorus opening ratio: maximum and minimum

    3 mins

  • Adverse effect of patients

    48 hours

  • VAS score of patient about procedure

    10 mins

  • Satisfaction of endoscopist

    10 mins

Study Arms (2)

L-menthol

EXPERIMENTAL

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

Drug: L-menthol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

L-mentholDRUG

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

Also known as: Peppermint oil
L-menthol
PlaceboDRUG

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

Also known as: Olive oil
Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \>65 years old
  • routine endoscopic examination
  • Contraindication to Buscopan(such as arrhythmia, glaucoma, benign prostatic hyperplasia, ischemic heart disease...)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35729250DERIVED

MeSH Terms

Interventions

Mentholpeppermint oilOlive Oil

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipidsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ming-Chih Hou, MD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih Hou, MD

CONTACT

886-2-28712121mchou@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 20, 2020

Study Start

March 1, 2012

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

TW(1)