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Clinical trial

Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy: A Double Blind, Randomized Controlled Trial.

ID
Name
MESE01
Description
In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD). The primary outcome of the study was comparison of total mucosal visibility score (TMVS) between combined pre-medication (Simethicone+ NAC) and individual pre-medication groups (Simethicone and NAC) in patients undergoing EGD. Secondary outcomes included comparison of TMVS between different groups, TMVS in early (10-20 min) versus late (\>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility was defined as a cumulative score of \<7 and ≥7, respectively.
Trial arms
Trial start
2022-06-16
Estimated PCD
2022-08-20
Trial end
2022-11-04
Status
Completed
Treatment
Simethicone 150mg
Impact of simethicone on the mucosal visibility of stomach and duodenum
Arms:
Simethicone 150 mg
Other names:
S
N Acetyl cysteine 600mg
Impact of N Acetyl cysteine on the mucosal visibility of stomach and duodenum
Arms:
N Acetyl cysteine 600 mg
Other names:
NAC
Simethicone 150mg plus N Acetyl cysteine 600 mg
Impact of simethicone plus N Acetyl cysteine on the mucosal visibility of stomach and duodenum
Arms:
Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination
Other names:
SPN
Placebo
Impact of water on the mucosal visibility of stomach and duodenum
Arms:
No Intervention
Other names:
W
Size
800
Primary endpoint
Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution
20 minutes
Eligibility criteria
Inclusion Criteria: * Adults (≥18-years) capable of giving written, informed consent will be included. * All eligible subjects undergoing diagnostic endoscopy will be recruited in the study. Exclusion Criteria: * History of upperGI tract surgery, * Gastric cancer * Need for therapeutic endoscopy and emergency procedures, * Recent upper GI bleeding * Caustic ingestion, * Pregnancy * Diabetes mellitus * Asthma * Allergic reactions to the medications used in the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 800, 'type': 'ACTUAL'}}
Updated at
2023-07-24

1 organization

3 products

1 indication

Organization
Asian Institute of Gastroenterology
Product
Simethicone
Indication
Mucosal Erosion
Product
N Acetyl Cysteine
Product
Simethicone + N Acetyl Cysteine