Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT01229527
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2010-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison Between Two Different Dosages of Remifentanil During Colonoscopy
Sponsor:
Organization:
Raw JSON
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The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient's Satisfaction", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Remifentanil RS1'}, {'id': 'OG001', 'title': 'Remifentanil RS2'}, {'id': 'OG002', 'title': 'Meperidine'}], 'classes': [{'categories': [{'measurements': [{'value': '95.87', 'spread': '9.72', 'groupId': 'OG000'}, {'value': '93.50', 'spread': '12.40', 'groupId': 'OG001'}, {'value': '96.27', 'spread': '7.62', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone', 'description': 'The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remifentanil RS1'}, {'id': 'FG001', 'title': 'Remifentanil RS2'}, {'id': 'FG002', 'title': 'Meperidine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Remifentanil RS1'}, {'id': 'BG001', 'title': 'Remifentanil RS2'}, {'id': 'BG002', 'title': 'Meperidine'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.93', 'spread': '11.15', 'groupId': 'BG000'}, {'value': '55.10', 'spread': '11.82', 'groupId': 'BG001'}, {'value': '60.37', 'spread': '10.48', 'groupId': 'BG002'}, {'value': '58.13', 'spread': '11.26', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-02', 'studyFirstSubmitDate': '2010-10-26', 'resultsFirstSubmitDate': '2011-09-19', 'studyFirstSubmitQcDate': '2010-10-26', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-02', 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discharge Time, the Time to Reach a Modified Aldrete Score ≥18', 'timeFrame': '> 0 minutes', 'description': 'Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.'}], 'secondaryOutcomes': [{'measure': "Patient's Satisfaction", 'timeFrame': 'After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone', 'description': 'The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.'}]}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Remifentanil', 'Sedation'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and side effects.\n\n90 patients undergoing colonoscopy will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Patients\n* Diagnostic and Operative Colonoscopy\n* ASA Physical Status I-II\n\nExclusion Criteria:\n\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT01229527', 'briefTitle': 'Comparison Between Two Different Dosages of Remifentanil During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Comparison Between Two Different Dosages of Remifentanil Administered by PCSA (Patient Controlled Sedation and Analgesia) and Meperidine During Colonoscopy: A Randomized Double-Blind Trial', 'orgStudyIdInfo': {'id': 'PCSA/Remi 2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remifentanil RS1', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'Remifentanil RS2', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meperidine', 'interventionNames': ['Drug: Meperidine']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'description': 'Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button.', 'armGroupLabels': ['Remifentanil RS1']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button.', 'armGroupLabels': ['Remifentanil RS2']}, {'name': 'Meperidine', 'type': 'DRUG', 'description': 'Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.', 'armGroupLabels': ['Meperidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Agostoni Massimo', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}