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COMPLETED
NCT07891455
NA

Sedation Depth and EGJ Endoscopic Grading: A Randomized Controlled Trial

Sponsor: Mohamed Abd El-Raouf Tawfik

View on ClinicalTrials.gov

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.

Official title: Unmasking Esophagogastric Junction Dysfunction: Effect of Anesthesia Depth on AFS-Based Endoscopic Assessment and GERD Severity

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2026-06-01

Completion Date

2026-09-30

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DEVICE

Upper gastrointestinal endoscopy

EGD

Locations (1)

Faculty of Medicine

Tanta, Egypt