Overview

Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
Summary
The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions. Before an upper endoscopy it is required a 6 hour fasting period[1]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus. To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure. The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Portuguese Oncology Institute, Coimbra
Treatments:
Acetylcysteine
N-monoacetylcystine
Simethicone
Criteria
Inclusion Criteria:

- consecutive series of patients scheduled for upper gastrointestinal endoscopy

- signed informed consent

Exclusion Criteria:

- sedation

- previous total gastrectomy

- known neoplasia or stenosis

- therapeutic or urgent procedures

- allergies to simethicone or N-acetylcysteine