Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT01841294
Status:
UNKNOWN
Last Update Posted:
2013-04-26
First Post:
2013-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2013-02-27', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of NKs activity after surgery', 'timeFrame': 'compare the activity of NK cells on day 1 and day 3 after surgery', 'description': 'Dosage of NKs activity after surgery'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'pain scores from the PACU to the 3rd day after surgery', 'description': 'From the PACU to the 3rd day after surgery'}, {'measure': 'Morphine consumption', 'timeFrame': 'From the PACU to the 3rd day after surgery', 'description': 'Morphine consumption from the PACU to the 3rd day after surgery'}, {'measure': 'Ileus time', 'timeFrame': 'Day 1 and Day 3 after surgery', 'description': 'time to get flattus after surgery'}, {'measure': 'Surgical complications', 'timeFrame': 'Within 3 days after surgery', 'description': 'Infections, leakage, abcess'}, {'measure': 'Fentanyl dose', 'timeFrame': 'Operative time', 'description': 'Cumulative dose of fentanyl needed for the surgery'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'From the PACU to the 3rd day after surgery', 'description': 'Nausea and vomiting from the PACU to the 3rd day after surgery'}, {'measure': 'Major adverses events', 'timeFrame': 'Start of the surgery untill one hour after PACU ad;ission', 'description': 'Hypotension, heart rythm blocks, tachycarida, bradycardia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread.\n\nA particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics.\n\nLidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well.\n\nThe authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted for resection of colorectal cancer under laparoscopic surgery\n* American Society of Anesthesiologists class I-III.\n* The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.\n\nExclusion Criteria:\n\n* Subjects allergic to any of the study drugs.\n* BMI \\> 35 kg/m2.\n* Severe renal or hepatic failure.\n* Pregnancy.\n* Emergent procedure.\n* Heart failure NYHA \\> III.\n* Systolic blood pressure \\< 90 mmHg.\n* Advanced heart block (unless patient has a pacemaker).\n* Unstable angina and/or myocardial infarction within past 6 weeks.\n* FEV1 ≤ 0.8 L.\n* Oxygen-dependent patient.\n* Electrocardiographic abnormalities\n* Treatment with immunosupressive drugs, corticosteroids, NSAIDS, antiarythmic\n* Morphine intolerance or allergy'}, 'identificationModule': {'nctId': 'NCT01841294', 'briefTitle': 'NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery', 'orgStudyIdInfo': {'id': '11077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous Lidocaine', 'description': 'Patients undergoing laparoscopic surgery for resection of colorectal cancer will benefit of an infusion of intravenous lidocaine from the induction of anesthesia untill one hour after PACU admission', 'interventionNames': ['Drug: Intravenous Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission', 'interventionNames': ['Drug: Normal saline infusion']}], 'interventions': [{'name': 'Intravenous Lidocaine', 'type': 'DRUG', 'otherNames': ['Chlorydrate de Lidocaine 2%'], 'description': 'Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h', 'armGroupLabels': ['Intravenous Lidocaine']}, {'name': 'Normal saline infusion', 'type': 'DRUG', 'description': 'Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nadia godin', 'role': 'CONTACT', 'email': 'ngodin.hmr@ssss.gouv.qc.ca', 'phone': '1 514 252 3400', 'phoneExt': '3153'}], 'facility': 'Hôpital Maisonneuve Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'louis-Philippe Fortier, M.D.', 'role': 'CONTACT', 'email': 'fortierlp@mac.com', 'phone': '1 514 252 3400'}], 'overallOfficials': [{'name': 'Louis-Philippe Fortier, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Louis-Philippe Fortier', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}