Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-01-20 @ 10:17 AM
Study NCT ID:
NCT02739958
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-19', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD3 plasma level', 'timeFrame': 'for 7 days after procedure', 'description': 'Venous blood samples will be collected. The extracted venous blood samples will be mixed evenly in a special anti-coagulation test tube and stored in a refrigerator (at 4C).Flow cytometer will be used to detect the level of CD3+'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'for 5 hours during the procedure', 'description': 'Intraoperative heart rate changes'}, {'measure': 'Blood pressure', 'timeFrame': 'for 5 hours during the procedure', 'description': 'Intraoperative blood pressure changes'}, {'measure': 'Peripheral oxygen saturation measured with pulse oximetry', 'timeFrame': 'for 5 hours during the procedure', 'description': 'Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer Larynx', 'Total Laryngectomy']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, randomized clinical study is to compare between propofol and isoflurane on perioperative immune cell populations and function in patients undergoing total laryngectomy surgery.', 'detailedDescription': 'The perioperative period might be a critical time in primary cancer surgery because many factors can affect whether recurrence, or metastasis , or elimination by the immune system.\n\nCancer surgery can induce an acute inflammatory response, due to local tissue damage and the shedding of malignant cells into the blood and lymphocytic circulation although meticulous surgical manipulation. Many evidences suggest that several factors during the perioperative period can affect the immune system.\n\nThese could be attributed to the surgery per se, pain, anxiety, hypothermia, blood transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may allow malignant cells to escape immuno-surveillance and metastasize in the perioperative period.As well as increase the risk of postoperative complications, such as systemic inflammatory response syndrome, sepsis, and multi-organ failure.\n\nPrevious retrospective clinical studies of both breast and prostate cancer surgery have suggested an association between anaesthetic technique and cancer recurrence.\n\nHowever ,other retrospective trials on various forms of cancer have shown no such benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status I- III\n* Scheduled for total laryngectomy.\n\nExclusion Criteria:\n\n* Patients refusal.\n* Morbid obese patients (body mass index \\>40 kg/m2).\n* Allergy to local anesthetics agents used.\n* Severely altered consciousness level.\n* Psychiatric disorders.\n* Severe or uncompensated cardiovascular disease.\n* Severe renal disease.\n* Severe hepatic disease.\n* Severe endocrinal diseases.'}, 'identificationModule': {'nctId': 'NCT02739958', 'briefTitle': 'Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia', 'orgStudyIdInfo': {'id': 'R/16.01.112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'Patients receive only intravenous anesthetics', 'interventionNames': ['Drug: Propofol group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isoflurane group', 'description': 'Patients receive isoflurane /fentanyl anesthesia', 'interventionNames': ['Drug: Isoflurane group']}], 'interventions': [{'name': 'Propofol group', 'type': 'DRUG', 'description': 'Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.', 'armGroupLabels': ['Propofol group']}, {'name': 'Isoflurane group', 'type': 'DRUG', 'description': 'Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments', 'armGroupLabels': ['Isoflurane group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Reem A El Sharkawy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Anesthesia and Surgical Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}