A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures

Starting soon · Not applicable

Conditions studied: Painless Gastrointestinal Endoscopy

In brief

Gastrointestinal endoscopy procedures, including upper gastrointestinal endoscopy and colorectal endoscopy, represent a fundamental and important method for examining and managing digestive tract diseases, with both diagnostic and therapeutic applications. They are also utilized as effective tools for surveillance of gastrointestinal tumors. During upper gastrointestinal endoscopy procedures, gastric peristalsis may restrict the operative field of view and access, significantly affecting procedural precision. Excessive peristalsis not only affects the observation of simple lesions but also impacts other procedural maneuvers Therefore, during upper gastrointestinal endoscopy procedures, antispasmodic agents are commonly used to suppress gastrointestinal motility, ultimately facilitating endoscopic visualization. However, most antispasmodic agents, such as hyoscine butylbromide (Buscopan), cimetropium bromide (Algiron), and atropine, must be administered by injection. Intravenous or intramuscular administration causes patient pain and anxiety, and increases medical costs. Some researchers have taken an alternative approach by spraying L-menthol onto the gastric mucosa during gastroscopy to reduce gastric peristalsis. Although study results and adverse reaction profiles have demonstrated its superiority, the application process still presents operational inconveniences. Furthermore, these drugs should be used with caution as they may cause potential adverse reactions, including dry mouth, urinary retention, temporary impairment of visual accommodation, palpitations, anaphylactic shock, and hyperglycemia.

Key facts

Study ID

NCT07271303

Run by

Shanghai Jiao Tong University School of Medicine

People needed

74

Starts

2026-02-01

Expected to finish

2026-12-01

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years and ≤75 years, regardless of sex;
• Patients scheduled to undergo painless gastrointestinal endoscopy examination or endoscopic surgery, which must include upper gastrointestinal endoscopy;
• Voluntary participation based on the free will of the subject or their legal guardian, with signed informed consent form.

You may not qualify if…

• Patients with a history of upper gastrointestinal surgery or colorectal surgery;
• American Society of Anesthesiologists (ASA) classification ≥ Grade III;
• Patients with severe cardiac conditions, including severe arrhythmia, structural heart disease, or other serious cardiac disorders;
• Significant hepatic or renal dysfunction affecting drug metabolism, defined as ALT > 2.5 × ULN, AST > 2.5 × ULN, or Scr > 1.5 × ULN;
• Organic pyloric stenosis, paralytic ileus, or other severe organic gastrointestinal diseases that are unsuitable for painless gastrointestinal endoscopy;
• Patients with suspected gastrointestinal ulcer bleeding or perforation;
• Patients with glaucoma or prostatic hypertrophy;
• Pregnant or lactating women;
• Known hypersensitivity to any component of the study drug;
• Use of medications affecting gastrointestinal motility within 7 days prior to study enrollment;
• Other conditions unsuitable for painless endoscopy procedures;
• Participation in another drug or medical device clinical trial within 30 days prior to study enrollment;
• Patients deemed unsuitable for participation in this clinical study by the investigator.

Full record on ClinicalTrials.gov

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