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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyoscine Butylbromide

    Drug

    Participants receive hyoscine butylbromide capsules orally before painless gastrointestinal endoscopy

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Hyoscine Butylbromide GroupExperimental treatment 1 intervention
Group B: Placebo groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
During endoscopy procedure

Secondary outcomes

1

Number of intestinal peristaltic movements per minute at intraoperative recording points

Evaluation method and criteria for intestinal 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.

Time frame
During endoscopy procedure
2

Procedural observation time

Defined as the time interval from endoscope insertion to complete withdrawal (recorded separately for upper gastrointestinal endoscopy and colorectal endoscopy).

Time frame
During endoscopy procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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