Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT04162535
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2019-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], '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': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2019-10-13', 'studyFirstSubmitQcDate': '2019-11-10', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the antiproliferative and apoptotic effects of anesthetic agents', 'timeFrame': 'up to 4 years', 'description': 'The investigators aim to correlate the anticancer effects of two anesthetic techniques with tumor markers (p53;p38) and cell proteins involved in proliferation or apoptosis (IGFR;Bcl-2;Bcl-6).\n\nThe investigators will report if the anesthetic agent used in cancer surgery influences the serologic values of these markers.'}, {'measure': 'Evaluation of patients serum on cell culture', 'timeFrame': 'up to 1 week', 'description': "The investigators will investigate the serum of the patients who received different types of anesthesia (elective colorectal cancer surgery) by incubating it with colon cell lines (HCT116). The investigators will concentrate on cell proliferation assay.\n\nThe investigators aim to discover how the growth of HCT116 will be influenced by patients' serum in terms of rate of proliferation. The measurements which will be used are Inhibitory Concentration (IC50) measured at 0 , 24 and 48 hours after incubation.\n\nThe concentrations will be measured in mcg/ml."}], 'secondaryOutcomes': [{'measure': 'Lidocaine concentration', 'timeFrame': 'up to 4 years', 'description': 'The investigators aim to determine de plasmatic concentration of lidocaine in the patients serum , which have received lidocaine perioperatively.\n\nThe investigators will do a Mass-Spec analysis of lidocaine'}, {'measure': 'Survival Comparison', 'timeFrame': 'up to 5 years', 'description': 'The investigators will do a follow up for the patients in all the 3 groups. The investigators want to investigate the survival ratio for the patients that had a elective colorectal cancer surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Propofol', 'Sevoflurane', 'Lidocaine', 'Cell Culture'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years old patients admitted for elective colorectal surgery\n\nExclusion Criteria:\n\n* Pre-existing chronic pain\n* Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids\n* Contraindications to any of the medications in the study\n* Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)\n* Hepatic (ALT and / or AST\\> 2 normal wave) or renal (serum creatinine\\> 2 mg / dl)\n* Convulsive conditions that require medication in the last 2 years\n* Planned regional analgesia and / or anesthesia (spinal or epidural)\n* Corticosteroid-dependent asthma\n* Autoimmune disorders\n* Antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine'}, 'identificationModule': {'nctId': 'NCT04162535', 'briefTitle': 'Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Contributions to the Elucidation of the Mechanisms and Effects by Which Certain Perianesthetic Interventions Modify Long-term Evolution of Patients With Digestive Cancers Subjected to Surgery', 'orgStudyIdInfo': {'id': '418/14.11.2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'description': 'Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent', 'interventionNames': ['Biological: Blood extraction', 'Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Total intravenous anesthesia', 'description': 'Patients will receive a general anesthesia with Propofol as anesthetic agent', 'interventionNames': ['Biological: Blood extraction', 'Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Total intravenous anesthesia and Lidocaine', 'description': 'Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol', 'interventionNames': ['Drug: Lidocaine 1% Injectable Solution', 'Biological: Blood extraction']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo', 'description': '10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison'}], 'interventions': [{'name': 'Lidocaine 1% Injectable Solution', 'type': 'DRUG', 'otherNames': ['Antiarrythmic drug'], 'description': 'Lidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm\n\n* Induction: 1.5 mg / kg i.v. bolus before induction (at the vein catch).\n* Maintaining anesthesia: continuous infusion with Lidocaine 2 mg / kg / h, up to a maximum of 200 mg / h during maintenance (after IOT until waking)\n* Infusion with 1% Lidocaine will be reduced to 1.0- 1.5 mg / kg / hour, max 100 mg / hour, for the first 48 hours postop', 'armGroupLabels': ['Total intravenous anesthesia and Lidocaine']}, {'name': 'Blood extraction', 'type': 'BIOLOGICAL', 'otherNames': ['Biologic Human Blood'], 'description': 'The patients will donate after consent 10 ml of blood prior and after surgery for further study', 'armGroupLabels': ['Sevoflurane', 'Total intravenous anesthesia', 'Total intravenous anesthesia and Lidocaine']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Volatile Anesthetic Drug'], 'description': 'Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Intravenous Anesthetic Drug'], 'description': 'Patients will receive a general anesthesia with Propofol as anesthetic agent', 'armGroupLabels': ['Total intravenous anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400469', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Alexandru Alexa', 'role': 'CONTACT', 'email': 'alexandru_reziati@yahoo.com', 'phone': '+40752691911'}], 'facility': 'Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Alexandru Alexa, MD', 'role': 'CONTACT', 'email': 'alexandru_reziati@yahoo.com', 'phone': '+40752691911'}, {'name': 'Ionescu Daniela, MD PHD', 'role': 'CONTACT', 'email': 'dionescuati@yahoo.com', 'phone': '0744771209'}], 'overallOfficials': [{'name': 'Ionescu Daniela, MD PHD DEEA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMF Iuliu Hatieganu Cluj-Napoca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor', 'class': 'OTHER'}, {'name': 'Prof. Dr. I. Chiricuta Institute of Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexandru Alexa', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}