Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy

NCT05951712 | Completed DMC

• 1 other identifier: MESE01
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD). The primary outcome of the study was comparison of total mucosal visibility score (TMVS) between combined pre-medication (Simethicone+ NAC) and individual pre-medication groups (Simethicone and NAC) in patients undergoing EGD. Secondary outcomes included comparison of TMVS between different groups, TMVS in early (10-20 min) versus late (\>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility was defined as a cumulative score of \<7 and ≥7, respectively.

Conditions

Mucosal Erosion

Outcome Measures

Primary Outcomes (1)

• Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution

  To achieve adequate mucosal visibility score visibilty score 0 means no mucus in duodenum, stomach

  20 minutes

Secondary Outcomes (1)

• Difference in the proportion of patients with adequate visibility score between the no intervention and the water plus simethicone solution, water plus N Acetyl cysteine solution, water plus simethicone and N Acetyl cysteine solution

  30 minutes

Study Arms (4)

No Intervention

PLACEBO COMPARATOR

In this arm, the participants will receive placebo ( 100 ml water) 10-30 minutes before the procedure under the supervision of a trained nurse. All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points: (1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with \<50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing.

Other: Placebo

Simethicone 150 mg

EXPERIMENTAL

In this arm, the participants will receive 150 mg simethicone dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with \<50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing.

Drug: Simethicone 150mg

N Acetyl cysteine 600 mg

EXPERIMENTAL

In this arm the participants will receive 600 mg N-acetyl cysteine dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments(gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with \<50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing.

Drug: N Acetyl cysteine 600mg

Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination

EXPERIMENTAL

In this arm, the participants will receive 150 mg simethicone and N-acetyl cysteine dissolved in 100 ml water 10-30 minutes before the procedure under the supervision of a trained nurse.All patients will be given standard recommendations before the procedure: at least 8 hours of liquid and solid fasting. During endoscopy, mucosal visibility will be evaluated in 6 segments (gastric antrum, lower gastric body, upper gastric body, fundus, first and second part of duodenum), using a scale ranging from 1 to 4 points:(1) no adherent mucus in the gastric mucosa examined; (2) a small amount of mucus in the gastric mucosa examined that does not hinder vision; (3) a large amount of mucus in the gastric mucosa examination, which can be washed thoroughly with \<50 mL of water; (4) a large amount of mucus in the gastric mucosa examined which requires ≥50 mL of water for washing.

Drug: Simethicone 150mg plus N Acetyl cysteine 600 mg

Interventions

Simethicone 150mg DRUG

Impact of simethicone on the mucosal visibility of stomach and duodenum

Also known as: S

Simethicone 150 mg

N Acetyl cysteine 600mg DRUG

Impact of N Acetyl cysteine on the mucosal visibility of stomach and duodenum

Also known as: NAC

N Acetyl cysteine 600 mg

Simethicone 150mg plus N Acetyl cysteine 600 mg DRUG

Impact of simethicone plus N Acetyl cysteine on the mucosal visibility of stomach and duodenum

Also known as: SPN

Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination

Placebo OTHER

Impact of water on the mucosal visibility of stomach and duodenum

Also known as: W

No Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18-years) capable of giving written, informed consent will be included.
• All eligible subjects undergoing diagnostic endoscopy will be recruited in the study.

You may not qualify if:

• History of upperGI tract surgery,
• Gastric cancer
• Need for therapeutic endoscopy and emergency procedures,
• Recent upper GI bleeding
• Caustic ingestion,
• Pregnancy
• Diabetes mellitus
• Asthma
• Allergic reactions to the medications used in the study

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian institute of Gastroenterology

Hyderabad, Telangana, 500079, India

Location

Related Publications (1)

• Nabi Z, Vamsi M, Goud R, Sayyed M, Basha J, Reddy PM, Reddy R, Reddy P, Manchu C, Darisetty S, Gupta R, Tandan M, Rao GV, Reddy DN. Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial. Indian J Gastroenterol. 2024 Oct;43(5):986-994. doi: 10.1007/s12664-023-01459-0. Epub 2023 Oct 18.

  PMID: 37848768 DERIVED

MeSH Terms

Interventions

Simethicone; Acetylcysteine

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Zaheer Dr Nabi, MD

  ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 19, 2023
• Study Start: June 16, 2022
• Primary Completion: August 20, 2022
• Study Completion: November 4, 2022
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)