GerdEGJ-SEDNCT07891455
Sedation Depth and EGJ Endoscopic Grading: A Randomized Controlled Trial
A study testing Upper gastrointestinal endoscopy in people with Gerd and Esophagogastric Junction, run by Mohamed Abd El-Raouf Tawfik at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gerd, Esophagogastric Junction, American Foregut Society Classification
- What is being tested?
- Upper gastrointestinal endoscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unmasking Esophagogastric Junction Dysfunction: Effect of Anesthesia Depth on AFS-Based Endoscopic Assessment and GERD Severity
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.
- Being tested
- Upper gastrointestinal endoscopy
- Keywords
- Esophagogastric junction, Ambulatory pH monitoring, Gastroesophageal reflux disease, Endoscopy, Sedation depth, American Foregut Society classification
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper gastrointestinal endoscopyDevice
Also called Gastroscopy
EGD
| Study group | Role | What they receive |
|---|---|---|
| Mild sedation | Active comparator | Propofol titration targeting an Observer's Assessment of Alertness/Sedation (MOAA/S) score of 4. Receives: Device: Upper gastrointestinal endoscopy |
| Moderate sedation | Active comparator | Propofol plus intermittent fentanyl titration targeting an MOAA/S score of 2-3. Receives: Device: Upper gastrointestinal endoscopy |
| Deep sedation | Active comparator | Propofol plus dexmedetomidine infusion targeting an MOAA/S score of 1-2. Receives: Device: Upper gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the diagnostic upper gastrointestinal endoscopy procedure (baseline pre-sedation vs. peak achieved sedation depth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GerdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Abd El-Raouf Tawfik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Abd El-Raouf Tawfik, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891455
- Sponsor's protocol ID
- 36265PR87/5/26
- Acronym
- EGJ-SED
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unmasking Esophagogastric Junction Dysfunction: Effect of Anesthesia Depth on AFS-Based Endoscopic Assessment and GERD Severity
- ClinicalTrials.gov ID
- NCT07891455
- Acronym / sponsor ID
- EGJ-SED / 36265PR87/5/26
- Keywords
- Esophagogastric junction, Ambulatory pH monitoring, Gastroesophageal reflux disease, Endoscopy, Sedation depth, American Foregut Society classification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Mohamed Abd El-Raouf TawfikUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild sedation | Active comparator | Device: Upper gastrointestinal endoscopyPropofol titration targeting an Observer's Assessment of Alertness/Sedation (MOAA/S) score of 4. |
| Moderate sedation | Active comparator | Device: Upper gastrointestinal endoscopyPropofol plus intermittent fentanyl titration targeting an MOAA/S score of 2-3. |
| Deep sedation | Active comparator | Device: Upper gastrointestinal endoscopyPropofol plus dexmedetomidine infusion targeting an MOAA/S score of 1-2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper gastrointestinal endoscopyAlso: GastroscopyEGD | Device | Deep sedation, Mild sedation, Moderate sedation |
Primary outcome
Change in American Foregut Society (AFS) Endoscopic Grade from Before to After Sedation
Time frame: During the diagnostic upper gastrointestinal endoscopy procedure (baseline pre-sedation vs. peak achieved sedation depth)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper gastrointestinal endoscopy in people with Gerd and Esophagogastric Junction, run by Mohamed Abd El-Raouf Tawfik at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in American Foregut Society (AFS) Endoscopic Grade from Before to After Sedation (time frame: During the diagnostic upper gastrointestinal endoscopy procedure (baseline pre-sedation vs. peak achieved sedation depth)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.