Sedation Depth and EGJ Endoscopic Grading: A Randomized Controlled Trial

NCT07891455 | Completed DMC

• 1 other identifier: 36265PR87/5/26
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gerd; Esophagogastric Junction; American Foregut Society Classification

Keywords

Esophagogastric junction; Ambulatory pH monitoring; Gastroesophageal reflux disease; Endoscopy; Sedation depth; American Foregut Society classification

Outcome Measures

Primary Outcomes (1)

• Change in American Foregut Society (AFS) Endoscopic Grade from Before to After Sedation

  Evaluation of esophagogastric junction (EGJ) integrity using official AFS criteria (axial length L, aperture D, and flap valve F; overall Grades I-IV) recorded immediately upon intubation (before sedation) and at peak achieved sedation depth (after sedation).

  During the diagnostic upper gastrointestinal endoscopy procedure (baseline pre-sedation vs. peak achieved sedation depth)

Study Arms (3)

Mild sedation

ACTIVE COMPARATOR

Propofol titration targeting an Observer's Assessment of Alertness/Sedation (MOAA/S) score of 4.

Device: Upper gastrointestinal endoscopy

Moderate sedation

ACTIVE COMPARATOR

Propofol plus intermittent fentanyl titration targeting an MOAA/S score of 2-3.

Device: Upper gastrointestinal endoscopy

Deep sedation

ACTIVE COMPARATOR

Propofol plus dexmedetomidine infusion targeting an MOAA/S score of 1-2.

Device: Upper gastrointestinal endoscopy

Interventions

Upper gastrointestinal endoscopy DEVICE

EGD

Also known as: Gastroscopy

Deep sedation; Mild sedation; Moderate sedation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Mohamed Abd El-Raouf Tawfik: lead

Study Sites (1)

Faculty of Medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Endoscopy, Digestive System; Gastroscopy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Endoscopy, Gastrointestinal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of internal medicine

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: September 30, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)