Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-26 @ 10:34 AM
Study NCT ID:
NCT02784860
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intravenous Lidocaine During Sedation for Colonoscopy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-29', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption of propofol', 'timeFrame': 'intraoperative', 'description': 'Dose of propofol administered during sedation if measured at the end of it.'}], 'secondaryOutcomes': [{'measure': 'Episodes of oxygen desaturation', 'timeFrame': 'intraoperative', 'description': 'Episodes of oxygen desaturation: SpO2 \\< 95 and 90%'}, {'measure': 'Time for recovery', 'timeFrame': 'intraoperative', 'description': 'the patient is discharged when conscious and able to give his birth date'}, {'measure': 'Quality of working conditions assessed by the gastroenterologist', 'timeFrame': 'intraoperative'}, {'measure': 'Abdominal discomfort', 'timeFrame': 'intraoperative and 15 minutes later', 'description': 'Evaluation with VAS (visual analog scale) form 0 (no discomfort) to 10 (unbearable Abdominal discomfort assessed on a 0 to 10 visual analog scale'}, {'measure': 'Postoperative fatigue', 'timeFrame': '15 min after sedation', 'description': 'Fatigue will be assessed on a visual analog scale'}, {'measure': 'Cognitive condition', 'timeFrame': '15 minutes after sedation', 'description': 'Cognitive condition will be evaluated with the MMSE (Minimal Mental State Examination)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'lidocaine', 'propofol', 'sedation'], 'conditions': ['Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '30336850', 'type': 'DERIVED', 'citation': 'Forster C, Vanhaudenhuyse A, Gast P, Louis E, Hick G, Brichant JF, Joris J. Intravenous infusion of lidocaine significantly reduces propofol dose for colonoscopy: a randomised placebo-controlled study. Br J Anaesth. 2018 Nov;121(5):1059-1064. doi: 10.1016/j.bja.2018.06.019. Epub 2018 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.\n\nSedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)', 'detailedDescription': 'The potential benefits of lidocaine infusion will be tested on:\n\n* propofol consumption (primary outcome)\n* intraoperative respiratory depression\n* time for patient recovery\n* postoperative fatigue\n* postoperative pain\n* postoperative cognitive dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* colonoscopy without gastroscopy\n\nExclusion Criteria:\n\n* lidocaine allergy\n* epilepsy\n* severe heart rhythm disorders\n* renal failure with creatinine clearance lower than 30ml/minute'}, 'identificationModule': {'nctId': 'NCT02784860', 'briefTitle': 'Effects of Intravenous Lidocaine During Sedation for Colonoscopy.', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Investigation of the Effects of Intravenous Lidocaine Infusion During Sedation for Colonoscopy', 'orgStudyIdInfo': {'id': 'LIDOCOLO2016JJCF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Administration of normal saline: same volume of saline as lidocaine.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['XYLOCAINE ; (NDA) 006488'], 'description': 'Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness', 'armGroupLabels': ['Lidocaine']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'University Hospital of Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Jean Joris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liege'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair', 'investigatorFullName': 'Jean François Brichant', 'investigatorAffiliation': 'University of Liege'}}}}