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

NCT07271303 | Not Yet Recruiting DMC

• 1 other identifier: LY2025-335-A
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Painless Gastrointestinal Endoscopy

Keywords

Painless gastrointestinal endoscopy; Hyoscine Butylbromide; Preoperative Preparation

Outcome Measures

Primary Outcomes (1)

• Number of gastric peristaltic movements per minute at intraoperative recording points

  Evaluation method and criteria for gastric peristalsis frequency: A third-party investigator will count the number of peristaltic movements from the endoscopic video recordings. After documenting the results, a statistician will calculate the mean value per minute.

  During endoscopy procedure

Secondary Outcomes (2)

• Number of intestinal peristaltic movements per minute at intraoperative recording points

  During endoscopy procedure

• Procedural observation time

  During endoscopy procedure

Study Arms (2)

Hyoscine Butylbromide Group

EXPERIMENTAL

Participants receive hyoscine butylbromide capsules orally before painless gastrointestinal endoscopy

Drug: Hyoscine Butylbromide

Placebo group

NO INTERVENTION

Participants receive matching placebo capsules orally before painless gastrointestinal endoscopy

Interventions

Hyoscine Butylbromide DRUG

Participants receive hyoscine butylbromide capsules orally before painless gastrointestinal endoscopy

Hyoscine Butylbromide Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Interventions

Butylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share