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Effect of Intraluminal Administration of Menthol Solution During Colonoscopy on Colonic Spasm and Adenoma Detection Rate

NCT07501962 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-03-30

No results posted yet for this study

Summary

In recent years, with increasing research into antispasmodic agents, topical antispasmodics have attracted considerable attention due to their direct action on the gastrointestinal mucosa and relatively low incidence of adverse reactions. Menthol, a natural terpenoid compound found in peppermint oil, has been confirmed by numerous studies to possess spasmolytic properties. Existing evidence indicates that menthol relaxes intestinal smooth muscle and alleviates spasm symptoms by antagonizing L-type calcium channels on the smooth muscle cell membrane, thereby reducing calcium influx. Furthermore, it exhibits local analgesic effects and can attenuate visceral hypersensitivity. Some studies suggest that oral or topical administration of peppermint oil preparations may improve intestinal spasm during colonoscopy, highlighting its potential utility in digestive endoscopy procedures. Nevertheless, current research on the spasmolytic efficacy and safety of menthol solution when administered via endoscopic irrigation during colonoscopy remains limited, and high-quality clinical trials are urgently needed for validation. This study aims to investigate the effectiveness and safety of menthol solution in relieving intestinal spasm, thereby providing scientific evidence for optimizing colonoscopy procedures.

Conditions

  • Colonoscopy

Interventions

DRUG

Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone.

Preparation method: Normal saline was used as the solvent. Menthol cyclodextrin inclusion complex (containing 7.3% menthol) was accurately weighed at 6.85 g and dissolved in 500 ml of normal saline to prepare a 0.1% menthol solution. After complete dissolution, 5 g of simethicone was added to form an aqueous suspension.

DRUG

Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline.

Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501962 on ClinicalTrials.gov