Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 7:30 AM
Study NCT ID:
NCT05951712
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2023-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}, {'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2023-06-25', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '20 minutes', 'description': 'To achieve adequate mucosal visibility score visibilty score 0 means no mucus in duodenum, stomach'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '30 minutes', 'description': 'To achieve adequate mucosal visibility score visibilty score 0 means no mucus in duodenum, stomach'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mucosal Erosion']}, 'referencesModule': {'references': [{'pmid': '37848768', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).\n\nThe 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.', 'detailedDescription': 'AIM: In this study, we aimed to evaluate the impact of premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD).\n\nThis 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).\n\nThe 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.\n\nRandomization 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.\n\nInterventions 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.\n\nA 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.\n\nAfter 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.\n\nMucosal 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.\n\nOutcome 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.\n\nSample 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18-years) capable of giving written, informed consent will be included.\n* All eligible subjects undergoing diagnostic endoscopy will be recruited in the study.\n\nExclusion Criteria:\n\n* History of upperGI tract surgery,\n* Gastric cancer\n* Need for therapeutic endoscopy and emergency procedures,\n* Recent upper GI bleeding\n* Caustic ingestion,\n* Pregnancy\n* Diabetes mellitus\n* Asthma\n* Allergic reactions to the medications used in the study'}, 'identificationModule': {'nctId': 'NCT05951712', 'acronym': 'SIMETHICONE', 'briefTitle': 'Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy: A Double Blind, Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'MESE01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'No Intervention', 'description': '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.\n\nDuring 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.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Simethicone 150 mg', 'description': '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.\n\nDuring 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.', 'interventionNames': ['Drug: Simethicone 150mg']}, {'type': 'EXPERIMENTAL', 'label': 'N Acetyl cysteine 600 mg', 'description': '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.\n\nDuring 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.', 'interventionNames': ['Drug: N Acetyl cysteine 600mg']}, {'type': 'EXPERIMENTAL', 'label': 'Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination', 'description': '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.\n\nDuring 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.', 'interventionNames': ['Drug: Simethicone 150mg plus N Acetyl cysteine 600 mg']}], 'interventions': [{'name': 'Simethicone 150mg', 'type': 'DRUG', 'otherNames': ['S'], 'description': 'Impact of simethicone on the mucosal visibility of stomach and duodenum', 'armGroupLabels': ['Simethicone 150 mg']}, {'name': 'N Acetyl cysteine 600mg', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': 'Impact of N Acetyl cysteine on the mucosal visibility of stomach and duodenum', 'armGroupLabels': ['N Acetyl cysteine 600 mg']}, {'name': 'Simethicone 150mg plus N Acetyl cysteine 600 mg', 'type': 'DRUG', 'otherNames': ['SPN'], 'description': 'Impact of simethicone plus N Acetyl cysteine on the mucosal visibility of stomach and duodenum', 'armGroupLabels': ['Simethicone (150 mg) plus N Acetyl cysteine 600 mg combination']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['W'], 'description': 'Impact of water on the mucosal visibility of stomach and duodenum', 'armGroupLabels': ['No Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500079', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Asian institute of Gastroenterology', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'Zaheer Dr Nabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Mohan Ramchandani', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}