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The effect of pretreatment with simethicone and acetylcysteine versus simethicone and pronase before upper gastrointestinal endoscopy: a single-center, single-blind, prospective, randomized controlled study

The effect of pretreatment with simethicone and acetylcysteine versus simethicone and pronase before upper gastrointestinal endoscopy: a single-center, single-blind, prospective, randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039403
Enrollment
Unknown
Registered
2020-10-26
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper gastrointestinal endoscopy

Interventions

A:Give the patient 100ml warm water + 600mg acetylcysteine + 400mg Simethicone orally 30 minutes before the upper gastrointestinal endoscopy.
B:Give the patient 100ml warm water + 20000U pronase + 1g sodium bicarbonate + 400mg simethicone orally 30 minutes before the upper gastrointestinal endoscopy.

Sponsors

Xi'an People's Hospital (Xi'an Fourth Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The subjects who can understand and sign the informed consent voluntarily; 2. Male or female aged 18 years or above; 3. The patient has indications for upper gastrointestinal endoscopy.

Exclusion criteria

Exclusion criteria: Patients with any of the following exclusion criteria could not be included in the study, as follows: 1. Patients with severe cardiopulmonary diseases can not tolerate endoscopy; 2. Patients with severe hypertension and poor blood pressure control; 3. In patients with gastrointestinal bleeding, blood pressure fluctuates greatly or is unstable; 4. In patients with severe bleeding tendency, hemoglobin was lower than 50g / L or PT prolonged for more than 1.5 seconds; 5. Patients who had received endoscopic treatment within 2 weeks before endoscopic examination; 6. Patients with high spinal deformity; 7. Huge diverticulum of digestive tract; 8. Patients suspected of shock or gastrointestinal perforation; 9. Patients with mental illness who cannot cooperate with endoscopy; 10. Patients with acute inflammation of digestive tract, especially patients with corrosive inflammation; 11. Patients with obvious thoracoabdominal aortic aneurysm; 12. Stroke patients; 13. Pregnant women; 14. Patients with poor compliance judged by researchers. 15. Patients who had participated in any clinical trial 14 days before inclusion; 16. Patients involved in research planning and implementation; 17. Patients included before the start of the study.

Design outcomes

Primary

MeasureTime frame
The vision clarity under gastroscopy;

Secondary

MeasureTime frame
Detection rate of gastric lesions;Amount of flushing during gastroscopy;Time of gastroscopy;Adverse event rate;

Countries

China

Contacts

Public ContactHuang Rui

Xi'an People's Hospital (Xi'an Fourth Hospital)

sangyahr@163.com+86 15091184930

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026