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临床试验/NCT06581783
NCT06581783已完成不适用

Impact of Timing of Premedication on Mucosal Visibility During Endoscopy

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,200
试验地点
1
主要终点
comparison of mucosal visibility between 4 groups

研究概览

简要总结

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)

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18years

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Simethicone plus NAC (Drug)

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.

干预措施: Simethicone plus NAC (Drug)

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.

干预措施: Simethicone plus NAC (Drug)

结局指标

主要结局

comparison of mucosal visibility between 4 groups

时间窗: 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 .

次要结局

  • To check adverse events during medication(30 minutes)
  • To identify the lesion detection rate(30 minutes)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

Doctor

Asian Institute of Gastroenterology, India

研究点 (1)

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