A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preope… (NCT07271303) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures
74 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of gastric peristaltic movements per minute at intraoperative recording points
Timeframe: During endoscopy procedure
Trial details
NCT IDNCT07271303
SponsorShanghai Jiao Tong University School of Medicine