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

NCT ID: NCT05951712

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-16
• Study Completion Date: 2022-11-04

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.

Detailed Description

AIM: In this study, we aimed to evaluate the impact of premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).

This is a single-centre, double blinded (patients and endoscopist), randomized trial at a tertiary care academic hospital and approved by institutional review board committee (AIG/IEC-BFI and R 29 /06.2022-04).

The eligibility criteria for enrollment into the study include adult patients (>18 y) undergoing esophagogastroduodenoscopy (EGD). Exclusion criteria for the study are history of upper gastrointestinal surgery, neurological disorder with impaired swallowing, active gastrointestinal bleeding, caustic ingestion, pregnancy, known history of multiple allergies, gastric outlet obstruction, esophageal motility disorders, and contraindication for EGD.

Randomization Patients will be randomly assigned to one of four categories. The randomization algorithm is generated using Random Allocation Software v2.0. Before EGD, a clinical research coordinator will deliver the sealed randomization envelopes to a trained nurse who will administer the solution to the patients after obtaining written informed consent from the study participants. In this trial, both patients and endoscopists will be unaware of the allocation.

Interventions Patients will be randomized to the following 4 groups: group A [100 mL of water (W)]; group B [150 mg simethicone (S)]; group C [600 mg NAC (NAC)]; and group D [150 mg simethicone +600 mg NAC (SPN)]. Patients, nursing staff assisting the procedure, the endoscopist performing the procedure, and the research coordinator collecting the data will be blinded. Identical bottles will be used in all the groups for the purpose of blinding.

A trained nurse not participating in the study will administer the solution 10-30 minutes before EGD. All patients will receive pharyngeal anesthesia with 4 squirts of 10% lidocaine (Xylocaine spray 10%; Neon, Thane, India) before EGD.

After EGD, all patients will be observed for two hours for any immediate adverse events. As feasible, delayed adverse events will be evaluated within 24 hours via telephone inquiry or in-person visits.

Mucosal visibility scoring A pre-defined scoring system will be used for grading mucosal visibility in four regions in stomach (fundus, proximal body, distal body and antrum) and two regions in duodenum [first (D1 and second (D2)]. The mucosal visibility scores range from 1 to 4 (1, no adherent mucus; 2, mild mucus, but not obscuring vision; 3, large amount of mucus obscuring vision, with less than 50 ml water required to clear it; 4, heavy adherent mucus, requiring more than 50 ml water to clear). Total mucosal visibility scores (TMVS) will be estimated by adding individual mucosal visibility scores in six different regions in stomach and duodenum. The TMVS ranges from 6 (best) to 24 (worst) points.

Outcome measures The primary outcome of the study is comparison of TMVS between combined pre-medication (SPN) and individual pre-medication groups (S and NAC) in patients undergoing EGD. Secondary outcomes include comparison of TMVS between different groups (A vs B vs C vs D), 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 is defined as a cumulative score of <7 and ≥7, respectively.

Sample size calculation In this study we aim to assess the impact of pre-medication on mucosal visibility (MVS) during EGD. We postulated that adequate MV will be at least 15% better in the combined pre-medication (WPSN) arm versus simethicone (WPS) arm.4 The sample size calculated was 346 (173 per group) to demonstrate the superiority of pre-medication with type 1 error as 0.05 and 80% power. Since, the study had four arms the estimated sample size was 692. Considering a 15% drop out rate during the follow-up, the number of cases to be enrolled was calculated to be 796 (199 in each group).

Conditions

Mucosal Erosion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

No Intervention

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Impact of water on the mucosal visibility of stomach and duodenum

Simethicone 150 mg

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.

Group Type: EXPERIMENTAL

Simethicone 150mg

Intervention Type: DRUG

Impact of simethicone on the mucosal visibility of stomach and duodenum

N Acetyl cysteine 600 mg

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.

Group Type: EXPERIMENTAL

N Acetyl cysteine 600mg

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

Simethicone 150mg plus N Acetyl cysteine 600 mg

Intervention Type: DRUG

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

Interventions

Simethicone 150mg

Impact of simethicone on the mucosal visibility of stomach and duodenum

Intervention Type: DRUG

N Acetyl cysteine 600mg

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

Intervention Type: DRUG

Simethicone 150mg plus N Acetyl cysteine 600 mg

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

Intervention Type: DRUG

Placebo

Impact of water on the mucosal visibility of stomach and duodenum

Intervention Type: OTHER

Other Intervention Names

S; NAC; SPN; W

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Mohan Ramchandani

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zaheer Dr Nabi, MD

Role: PRINCIPAL_INVESTIGATOR

ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS

Locations

Asian institute of Gastroenterology

Hyderabad, Telangana, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 37848768 (View on PubMed)

Other Identifiers

MESE01

Identifier Type: -

Identifier Source: org_study_id