Clinical trial NCT06581783: Impact of Timing of Premedication on Mucosal Visibility During Endoscopy-A Randomized Controlled Trial
Official title: Impact of Timing of Premedication on Mucosal Visibility During Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy, Digestive System
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 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

1. No adherent mucus and clear views of the mucosa.
2. A thin coating of mucus that did not obscure views of the mucosa.
3. Some mucus/bubbles partially obscuring views of the mucosa (i. E. A small mucosal lesion might be missed without flushing
4. 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

Eligibility criteria: Inclusion Criteria:

Age \>18years

Exclusion Criteria:

* History of upper gastrointestinal surgery
* Neurological disorders with impaired swallowing
* Active gastrointestinal bleeding,
* Caustic ingestion
* Pregnancy.
* Known history of multiple allergies
* Gastric outlet obstruction
* Esophageal motility disorders
* Contraindication for upper GI endoscopy

Primary outcomes:
measure: comparison of mucosal visibility between 4 groups
timeFrame: 10-30 minutes
Secondary outcomes:
measure: To check adverse events during medication
timeFrame: 30 minutes
measure: To identify the lesion detection rate
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology /Aig Hospitals
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: zaheer Dr Nabi, MBBS MD DNB
role: PRINCIPAL_INVESTIGATOR
References: