Endoscopy, Digestive SystemENDONCT06581783
Impact of Timing of Premedication on Mucosal Visibility During Endoscopy-A Randomized Controlled Trial
A study testing Simethicone plus NAC in people with Endoscopy, Digestive System, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
UGI endoscopy(esophagogastroduodenoscopy) is the main diagnostic modality for direct visualization ,real time assessment and interpretation of findings encountered. The evaluation of esophagogastroduodenoscopy (EGD) quality measures encompasses several categories, such as structure, procedure, result, and adverse… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Digestive System
- What is being tested?
- Simethicone plus NAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2024to 29 Apr 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18years
Who cannot join
- History of upper gastrointestinal surgery
- Neurological disorders with impaired swallowing
- Active gastrointestinal bleeding,
- Caustic ingestion
- Pregnancy.
- Known history of multiple allergies
Show all 9Show fewer
- Gastric outlet obstruction
- Esophageal motility disorders
- Contraindication for upper GI endoscopy
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, 500082
About this study
Official title: Impact of Timing of Premedication on Mucosal Visibility During Endoscopy
UGI endoscopy(esophagogastroduodenoscopy) is the main diagnostic modality for direct visualization ,real time assessment and interpretation of findings encountered. The evaluation of esophagogastroduodenoscopy (EGD) quality measures encompasses several categories, such as structure, procedure, result, and adverse events. The peri-EGD period procedures fall under the procedural area, which is primarily concerned with preventing and minimising missed diagnoses.
. More aid in the identification and characterisation of gastrointestinal mucosal lesions is provided by endoscopes equipped with improved imaging technologies, such as multiband or narrow-band imaging (NBI). Despite these advancements of technological aspects, the unclean mucosal surface of the stomach can make these high-end pieces of equipment virtually useless To visualize properly and diagnose accurately there should be clear visibility of mucus apart from operator experience. Since the stage at diagnosis of upper gastrointestinal cancer is a major factor in survival, early detection is essential in improving the prognosis of patients the main factors responsible for hinderance of mucosal visibility are mucus foam and bubbles, which requires additional care for the clearance to enhance the vision and also decrease endoscopy duration by alleviating the need of repeated flushing and suctioning during endoscopy. The froth and bubbles are made of mucous secretions mixed with gastric juice and bile. Simethicone (polydimethylsiloxane and silicon dioxide) has been proven to be a promising defoaming agent as an endoscopic premedication in removing bubbles . Simethicone works by reducing the surface tension of air bubbles, and releases the trapped air by causing small bubbles to coalesce and collapse . N-acetylcysteine (nac), a mucolytic agent, has also been used as premedication acts by removing the mucous overlying the gastrointestinal mucosa 4-point scale described by Basford et al
- No adherent mucus and clear views of the mucosa.
- A thin coating of mucus that did not obscure views of the mucosa.
- Some mucus/bubbles partially obscuring views of the mucosa (i. E. A small mucosal lesion might be missed without flushing
- Heavy mucus/bubbles obscuring views of the mucosa (i. E. Extensive flushing is needed to avoid missing small mucosal lesions)
Read the detailed description
Procedure
- Premixed medication (150mg simethicone and 600mg nac with 100ml of water) was given at specified timing Primary objective - comparison of mucosal visibility between 4 groups Secondary objectives - adverse events adequate gastric mucosal visibility lesion detection rate
- Conditions
- Endoscopy, Digestive System
- Being tested
- Simethicone plus NAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone plus NACDrug
Also called placebo (water)
Drug simethicone plus N acetylcysteine will be given before endoscopy with different time intervals
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Normal endoscopic patients with out medication is required to compare with active groups. |
| simethicone plus NAC combination time interval greater than 30 minutes | Experimental | Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given >30minutes for 273 patients. Receives: Drug: Simethicone plus NAC |
| simethicone plus NAC 10 to 20 minutes | Experimental | Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given 10-20 minutes time interval for 273 patients. Receives: Drug: Simethicone plus NAC |
| simethicone plus NAC 20 to 30 minutes | Experimental | Premixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given 20-30minutes for 273 patients. Receives: Drug: Simethicone plus NAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of mucosal visibility between 4 groups
Scores will be given based on Basford scale for esophagus, stomach (four parts: Cardia, fundus, body, antrum), Duodenum (D1, D2), score 1 indicates No adherent mucus and clear views of the mucosa, score 2 indicates A thin coating of mucus that did not obscure views of the mucosa, score 3 indicates some mucus/bubbles partially obscuring views of the mucosa score 4 indicates Heavy mucus obscuring views of the mucosa .
Measured: 10-30 minutes
Secondary outcomes (2)
To check adverse events during medication
adverse events may happen due to simethicone medicine like itching etc
Measured: 30 minutes
To identify the lesion detection rate
During endoscopy procedure with different time intervals the lesions were noted
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Dec 2024
- Primary completion18 Feb 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopy, Digestive SystemStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- zaheer Dr Nabi, MBBS MD DNB, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581783
- Sponsor's protocol ID
- POMVDE
- Acronym
- ENDO
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nabi Z, Dasireddy PS, Sayyed M, Reddy P, Goud R, Rughwani H, Singh AP, Inavolu P, Reddy PM, Basha J, Gupta R, Tandan M, Reddy DN. Impact of Timing of Premedication on Mucosal Visibility During Endoscopy: A Randomized Controlled Trial. J Gastroenterol Hepatol. 2026 Jun;41(6):1874-1882. doi: 10.1111/jgh.70392. Epub 2026 Apr 10.
PubMed 41960652
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Timing of Premedication on Mucosal Visibility During Endoscopy
- ClinicalTrials.gov ID
- NCT06581783
- Acronym / sponsor ID
- ENDO / POMVDE
- Conditions
- Endoscopy, Digestive System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 3 Sep 2024 (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.
UGI endoscopy(esophagogastroduodenoscopy) is the main diagnostic modality for direct visualization ,real time assessment and interpretation of findings encountered. The evaluation of esophagogastroduodenoscopy (EGD) quality measures encompasses several categories, such as structure, procedure, result, and adverse events. The peri-EGD period procedures fall under the procedural area, which is primarily concerned with preventing and minimising missed diagnoses.
. More aid in the identification and characterisation of gastrointestinal mucosal lesions is provided by endoscopes equipped with improved imaging technologies, such as multiband or narrow-band imaging (NBI). Despite these advancements of technological aspects, the unclean mucosal surface of the stomach can make these high-end pieces of equipment virtually useless To visualize properly and diagnose accurately there should be clear visibility of mucus apart from operator experience. Since the stage at diagnosis of upper gastrointestinal cancer is a major factor in survival, early detection is essential in improving the prognosis of patients the main factors responsible for hinderance of mucosal visibility are mucus foam and bubbles, which requires additional care for the clearance to enhance the vision and also decrease endoscopy duration by alleviating the need of repeated flushing and suctioning during endoscopy. The froth and bubbles are made of mucous secretions mixed with gastric juice and bile. Simethicone (polydimethylsiloxane and silicon dioxide) has been proven to be a promising defoaming agent as an endoscopic premedication in removing bubbles . Simethicone works by reducing the surface tension of air bubbles, and releases the trapped air by causing small bubbles to coalesce and collapse . N-acetylcysteine (nac), a mucolytic agent, has also been used as premedication acts by removing the mucous overlying the gastrointestinal mucosa 4-point scale described by Basford et al
- No adherent mucus and clear views of the mucosa.
- A thin coating of mucus that did not obscure views of the mucosa.
- Some mucus/bubbles partially obscuring views of the mucosa (i. E. A small mucosal lesion might be missed without flushing
- Heavy mucus/bubbles obscuring views of the mucosa (i. E. Extensive flushing is needed to avoid missing small mucosal lesions)
Detailed description
Procedure
- Premixed medication (150mg simethicone and 600mg nac with 100ml of water) was given at specified timing Primary objective - comparison of mucosal visibility between 4 groups Secondary objectives - adverse events adequate gastric mucosal visibility lesion detection rate
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Normal endoscopic patients with out medication is required to compare with active groups. |
| simethicone plus NAC combination time interval greater than 30 minutes | Experimental | Drug: Simethicone plus NACPremixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given >30minutes for 273 patients. |
| simethicone plus NAC 10 to 20 minutes | Experimental | Drug: Simethicone plus NACPremixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given 10-20 minutes time interval for 273 patients. |
| simethicone plus NAC 20 to 30 minutes | Experimental | Drug: Simethicone plus NACPremixed medication (150mg) simethicone and 600mg nac with 100ml of water has to be given 20-30minutes for 273 patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18years
Key exclusion criteria (9 listed)
- History of upper gastrointestinal surgery
- Neurological disorders with impaired swallowing
- Active gastrointestinal bleeding,
- Caustic ingestion
- Pregnancy.
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 |
|---|---|---|
| Simethicone plus NACAlso: placebo (water)Drug simethicone plus N acetylcysteine will be given before endoscopy with different time intervals | Drug | simethicone plus NAC 10 to 20 minutes, simethicone plus NAC 20 to 30 minutes, simethicone plus NAC combination time interval greater than 30 minutes |
Primary outcome
comparison of mucosal visibility between 4 groups
Time frame: 10-30 minutes
Scores will be given based on Basford scale for esophagus, stomach (four parts: Cardia, fundus, body, antrum), Duodenum (D1, D2), score 1 indicates No adherent mucus and clear views of the mucosa, score 2 indicates A thin coating of mucus that did not obscure views of the mucosa, score 3 indicates some mucus/bubbles partially obscuring views of the mucosa score 4 indicates Heavy mucus obscuring views of the mucosa .
2 secondary outcomes
To check adverse events during medication
Time frame: 30 minutes
To identify the lesion detection rate
Time frame: 30 minutes
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 6 May 2025.
- Derived from this study: PubMed 41960652Nabi Z, Dasireddy PS, Sayyed M, Reddy P, Goud R, Rughwani H, Singh AP, Inavolu P, Reddy PM, Basha J, Gupta R, Tandan M, Reddy DN. Impact of Timing of Premedication on Mucosal Visibility During Endoscopy: A Randomized Controlled Trial. J Gastroenterol Hepatol. 2026 Jun;41(6):1874-1882. doi: 10.1111/jgh.70392. Epub 2026 Apr 10.
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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.
zaheer Dr Nabi, MBBS MD DNB principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simethicone plus NAC in people with Endoscopy, Digestive System, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. 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 India. 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?
comparison of mucosal visibility between 4 groups (time frame: 10-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581783, which also lists 1 linked publication.
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 6 May 2025.