Painless digestive endoscopy operation
Conditions
Interventions
Trial Group:Scopolamine Butanebromide Capsules 20mg, oral administration 30+/-5 minutes before surgery, 2 tablets each time
Placebo Group:Placebo with identical appearance to Scopolamine Butanebromide Capsules 20mg, oral administration 30+/-5 minutes before surgery, 2 tablets each time
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 75 years, inclusive, of either sex; 2. Patients scheduled to undergo sedated gastrointestinal endoscopic examination or endoscopic surgery, which must include an upper gastrointestinal endoscopic procedure; 3. Subjects who voluntarily agree to participate of their own free will (or with consent provided by their legal guardian, where applicable) and who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of prior upper gastrointestinal surgery or colorectal surgery; 2. American Society of Anesthesiologists (ASA) physical status classification >= III; 3. Presence of serious cardiac disease, including severe arrhythmia or structural heart disease; 4. Significant hepatic or renal dysfunction that may affect drug metabolism, defined as ALT > 2.5 × ULN, AST > 2.5 × ULN, or serum creatinine (Scr) > 1.5 × ULN; 5. Organic pyloric stenosis, paralytic ileus, or other severe organic gastrointestinal diseases that make sedated gastrointestinal endoscopy unsuitable; 6. Suspected gastrointestinal ulcer bleeding or perforation; 7. Glaucoma or prostatic hyperplasia; 8. Pregnant or breastfeeding women; 9. Known allergy or hypersensitivity to any component of the investigational drug; 10. Use of medications affecting gastrointestinal motility within 7 days before study participation; 11. Any other condition that makes the patient unsuitable for sedated endoscopy; 12. Participation in any other drug or medical device clinical study within 30 days before enrollment; 13. Any patient deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric peristaltic rate during surgery (per minute); | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal peristaltic rate during surgery (per minute);Surgical observation duration;Intraoperative observation score;Visual Analog Scale (VAS) within 24 hours postoperatively;Incidence of cough and aspiration during surgery; | — |
Countries
China
Contacts
Public ContactLi Xiaobo
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed