Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT00930358
Status:
TERMINATED
Last Update Posted:
2011-04-06
First Post:
2009-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Colonoscopy Under Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C576493', 'term': 'Meopa'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'whyStopped': 'This study was stopped due to low inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-06-29', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who have well tolerated the colonoscopy as assessed by visual analogic scale (>75/100)', 'timeFrame': 'Immediately after the colonoscopy'}, {'measure': 'The mean grade of patient anxiety before endoscopy', 'timeFrame': 'After the colonoscopy', 'description': 'The mean grade of patient anxiety before endoscopy'}], 'secondaryOutcomes': [{'measure': 'The mean tolerability of the colonoscopy between the group with sedation by nitrous oxide/oxygen mixture and the group with anesthesia', 'timeFrame': 'after the colonoscopy'}, {'measure': 'The mean pain intensity during the procedure on a visual analogic scale', 'timeFrame': 'after the colonoscopy'}, {'measure': 'The mean patient satisfaction on a visual analogic scale.', 'timeFrame': 'after the colonoscopy'}, {'measure': 'The percentage of patients who agree to repeat the procedure in similar circumstances.', 'timeFrame': 'after the colonoscopy'}, {'measure': 'The grade of difficulty of the colonoscopy evaluated by the endoscopist', 'timeFrame': 'After the colonoscopy'}, {'measure': 'The mean duration of the endoscopy', 'timeFrame': 'After the colonoscopy'}, {'measure': 'The percentage of caecum intubation', 'timeFrame': 'After the colonoscopy'}, {'measure': 'The percentage of ileal intubation', 'timeFrame': 'After the colonoscopy'}, {'measure': 'The opinion of the endoscopist on the tolerance of the colonoscopy', 'timeFrame': 'After the colonoscopy'}, {'measure': 'The time to hospital discharge', 'timeFrame': 'After the issue of the colonoscopy'}, {'measure': "The Aldrete's score at the hospital discharge", 'timeFrame': 'After the colonoscopy'}, {'measure': 'The number of patient who have refused the inclusion', 'timeFrame': 'After the issue of the colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sedation', 'Colonoscopy', 'General anesthesia'], 'conditions': ['Colonoscopy Procedure']}, 'referencesModule': {'references': [{'pmid': '9083731', 'type': 'BACKGROUND', 'citation': 'Trojan J, Saunders BP, Woloshynowych M, Debinsky HS, Williams CB. Immediate recovery of psychomotor function after patient-administered nitrous oxide/oxygen inhalation for colonoscopy. Endoscopy. 1997 Jan;29(1):17-22. doi: 10.1055/s-2007-1004055.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy', 'detailedDescription': 'The purpose of this protocol is to compare two methods of analgesia/sedation for colonoscopy. Sedation and analgesia induced by a 50% nitrous oxide/oxygen mixture could sufficient to allow the practice of colonoscopy instead of general anesthesia which is accompanied with certain risks and post procedure drowsiness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient referred for colonoscopy with general anesthesia\n2. Age above 18 et below 75 year\n3. Patient who gave an informed consent\n\nExclusion Criteria:\n\n1. Age below 18 ou above 75\n2. Need for gastroscopy in the same procedure than colonoscopy\n3. History of surgery wih resection more extended than half of the colon\n4. Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic\n5. Severe congestive heart failure or evolutive heart ischemia\n6. Recent cerebral stroke\n7. Hemodynamic instability\n8. Respiratory failure, severe chronic obstructive pulmonary (including asthma) or progressive pneumothorax\n9. Hepatic failure (Child-Pugh score\\> 9)\n10. Terminal renal failure 11 Hematopoietic disorders\n\n12\\. Pathology with expected survival shorter than the duration of the study and cancer excepted basal cell carcinoma of the skin 13. Alcohol consumption higher than 100 gr per day 14. Pregnancy or breastfeeding at the inclusion period'}, 'identificationModule': {'nctId': 'NCT00930358', 'acronym': 'KALINAG', 'briefTitle': 'Safety Study of Colonoscopy Under Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Tolerance and Acceptability of Colonoscopy Under Sedation by an Equimolar Mixture of Oxygen and Nitrous Oxide. Comparison With General Anesthesia in a Randomized, Multicentric Study.', 'orgStudyIdInfo': {'id': 'P060240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEOPA', 'description': 'MEOPA : equimolar nitrous oxide/oxygen mixture', 'interventionNames': ['Drug: MEOPA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia', 'description': 'Gold standard', 'interventionNames': ['Drug: general anaesthesia']}], 'interventions': [{'name': 'MEOPA', 'type': 'DRUG', 'otherNames': ['anaesthetic gaz inhalation'], 'description': 'anaesthetic gaz inhalation', 'armGroupLabels': ['MEOPA']}, {'name': 'general anaesthesia', 'type': 'DRUG', 'otherNames': ['Anaesthetic intravenous route'], 'description': 'Anaesthetic intravenous route', 'armGroupLabels': ['General anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Dominique Lamarque, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cécile Kedzia', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}