Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT01547520
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2012-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-04-25', 'releaseDate': '2012-04-02'}], 'estimatedResultsFirstSubmitDate': '2012-04-02'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2012-02-28', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'discomfort score during esophageal intubation', 'timeFrame': '9 months', 'description': 'patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'patient and endoscopist satisfaction score', 'timeFrame': '9 months', 'description': 'patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied'}, {'measure': 'patient tolerance of the procedure', 'timeFrame': '9 months', 'description': 'patolerace of the EGD, evaluate by the endoscopist, score 0 (best tolerance)-10 (very poor tolerance, the procedure could not be completed)'}, {'measure': 'endoscopist perception of patient tolerance ,', 'timeFrame': '9 months', 'description': 'endoscopist evaluation of patient tolerance during EGD, score 0 (best tolerance)- 10 (worst tolerance, the procedure can not be completed)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['meperidine', 'esophagogastroduodenoscopy', 'unsedated', 'minimal sedation'], 'conditions': ['Esophagogastroduodenoscopy']}, 'referencesModule': {'references': [{'pmid': '15330904', 'type': 'BACKGROUND', 'citation': 'Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.'}, {'pmid': '1473671', 'type': 'BACKGROUND', 'citation': 'Ishido S, Kinoshita Y, Kitajima N, Itoh T, Nishiyama K, Tojo M, Yano T, Inatome T, Fukuzaki H, Chiba T. Fentanyl for sedation during upper gastrointestinal endoscopy. Gastrointest Endosc. 1992 Nov-Dec;38(6):689-92. doi: 10.1016/s0016-5107(92)70565-3.'}, {'pmid': '11231385', 'type': 'BACKGROUND', 'citation': 'Laluna L, Allen ML, Dimarino AJ Jr. The comparison of midazolam and topical lidocaine spray versus the combination of midazolam, meperidine, and topical lidocaine spray to sedate patients for upper endoscopy. Gastrointest Endosc. 2001 Mar;53(3):289-93. doi: 10.1016/s0016-5107(01)70400-2.'}, {'pmid': '8651156', 'type': 'BACKGROUND', 'citation': 'Diab FH, King PD, Barthel JS, Marshall JB. Efficacy and safety of combined meperidine and midazolam for EGD sedation compared with midazolam alone. Am J Gastroenterol. 1996 Jun;91(6):1120-5.'}, {'pmid': '23431993', 'type': 'DERIVED', 'citation': 'Hsieh YH, Lin HJ, Hsieh JJ, Tseng KC, Tseng CW, Hung TH, Leung FW. Meperidine as the single sedative agent during esophagogastroduodenoscopy, a double-blind, randomized, controlled study. J Gastroenterol Hepatol. 2013 Jul;28(7):1167-73. doi: 10.1111/jgh.12183.'}]}, 'descriptionModule': {'briefSummary': 'Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and analgesic effects, so its use may be helpful for patients receiving upper endoscopy.', 'detailedDescription': 'Unsedated esophagogastroduodenoscopy (EGD) is a useful tool for upper gastrointestinal tract examination and therapy, but it is uncomfortable for many patients. Meperidine has been widely used in colonoscopic examination for many years; however, its use in EGD has not been completely evaluated.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.\n\nExclusion Criteria:\n\n* A therapeutic upper endoscopic procedure, sedated endoscopy, contraindication to Buscopan (hyoscine N-butylbromide)\n* Allergy to meperidine\n* American Society of Anesthesiology (ASA) risk Class 3 or higher\n* Renal failure\n* Decompensated cirrhosis\n* Aged less than 20 years or more than 65 years\n* Pregnancy\n* Refusal to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT01547520', 'briefTitle': 'Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Dalin Tzu Chi General Hospital'}, 'officialTitle': 'Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'DalinTCGH-hsieh-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'meperidine', 'description': '25 mg of meperidine is injected intramuscularly before EGD', 'interventionNames': ['Drug: Meperidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo was given intramuscularly before EGD', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Meperidine', 'type': 'DRUG', 'description': 'intramuscular, 25 mg, 5 to 10 minutes before EGD', 'armGroupLabels': ['meperidine']}, {'name': 'normal saline', 'type': 'DRUG', 'description': '25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '622', 'city': 'Chiayi City', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Dalin Tzu Chi General Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}], 'overallOfficials': [{'name': 'Yu-Hsi Hsieh, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalin Tzu Chi General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalin Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-04-02', 'type': 'RELEASE'}, {'date': '2012-04-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dalin Tzu Chi General Hospital'}}}}