An interventional study of Endoscopic irrigation was performed using a 0.1% menthol solution combined with simethicone. and Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline. in Colonoscopy, sponsored by The First Affiliated Hospital of Zhengzhou University. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Not applicable, Interventional, and Diagnostic
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.
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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 a 0.1% menthol solution combined with simethicone.
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.
Drug: Endoscopic irrigation was performed using an aqueous suspension prepared with simethicone and normal saline.
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.
Preparation method: 5 g of simethicone was added to 500 ml of normal saline to form the aqueous suspension.
Incidence of intestinal spasm
Intestinal spasm score: Score 1 (Excellent): No spasm; the lumen opening is greater than or equal to two-thirds of the maximum diameter. Score 2 (Moderate): Moderate spasm; the lumen opening is less than two-thirds of the maximum diameter. Score 3 (Poor): Severe spasm; the oral-side lumen cannot be visualized. The maximum diameter is defined as the diameter of the intestinal lumen when fully distended. Spasm incidence: The percentage of patients with an intestinal spasm score of 2 or 3 out of the total number of patients in the group.
Time frame: Day 0
adenoma detection rate (ADR)
ADR = (Number of patients with at least one adenomatous polyp detected / Total number of patients in the group) × 100%. Pathological diagnosis was used as the gold standard.
Time frame: Day 0
Spasm inhibition rate
The percentage of patients whose lumen opening exceeded two-thirds of the maximum diameter within 30 seconds after water injection irrigation, relative to the total number of patients in the group.
Time frame: Day 0
Polyp detection rate (PDR)
PDR = (Number of patients with at least one polyp detected / Total number of patients in the group) × 100%.
Time frame: Day 0
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The First Affiliated Hospital of Zhengzhou University