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Completed
NCT07891455
Sedation Depth and EGJ Endoscopic Grading: A Randomized Controlled Trial
Conditions: Gerd, Esophagogastric Junction, American Foregut Society Classification
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 192
Sponsor: Mohamed Abd El-Raouf Tawfik
Location: Faculty of Medicine Tanta
Summary
Brief Study Summary:
This prospective randomized controlled trial evaluates the impact of procedural sedation depth on the American Foregut Society (AFS) endoscopic grading of esophagogastric junction (EGJ) integrity and its correlation with objective gastroesophageal reflux disease (GERD) severity. A total of 192 adult patients undergoing diagnostic upper endoscopy were randomly allocated across three active sedation arms (Mild, Moderate, and Deep Sedation). Using a dual assessment protocol, AFS grades were recorded before and after sedation to assess how suppressing neuromuscular reflex tone unmasks underlying structural EGJ incompetence, with results correlated against baseline validated GerdQ scores, Los Angeles esophagitis grades, and 24-hour ambulatory pH-impedance monitoring.
Eligibility Criteria
Inclusion criteria Age 18 to 75 years Referred for diagnostic upper gastrointestinal endoscopy for evaluation of upper gastrointestinal symptoms (such as heartburn, regurgitation, chest pain, or dyspepsia) or clinical surveillance GerdQ score \\ge 6 Ability to understand and provide written informed consent Exclusion Criteria Prior upper gastrointestinal, bariatric, or antireflux surgery Known primary esophageal motility disorders (e.g., achalasia, distal esophageal spasm) Large fixed hiatal hernia (\\ge 5\\text{ cm} or paraesophageal hernia) Active upper gastrointestinal bleeding Severe cardiopulmonary instability Pregnancy
Source: ClinicalTrials.gov (NCT07891455). StuddyBuddy aggregates publicly available trial information.