Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-07 @ 6:26 AM
Study NCT ID:
NCT06418893
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, controlled, double blind'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-05-13', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.', 'timeFrame': 'INTRAOPERATIVELY', 'description': 'TCI propofol will provide more stable hemodynamics'}], 'secondaryOutcomes': [{'measure': 'To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes', 'timeFrame': 'INTRAOPERATIVELY AT 15 MINUTES INTERVAL'}, {'measure': 'To compare between the two groups mean systemic vascular resistance during different phases of liver transplant recorded every 15 minutes', 'timeFrame': 'INTRAOPERATIVELY AT 15 MINUTES INTERVAL'}, {'measure': 'To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes', 'timeFrame': 'INTRAOPERATIVELY AT 15 MINUTES INTERVAL'}, {'measure': 'Total vasopressor requirement during reperfusion', 'timeFrame': 'Intraoperative'}, {'measure': 'Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively', 'timeFrame': 'Intraoperatively'}, {'measure': 'QTc interval between the two groups during different phases of liver transplant measured every 15 minutes', 'timeFrame': 'Intraoperatively every 15 mins'}, {'measure': 'Peak lactate levels intraoperatively', 'timeFrame': 'Intraoperatively'}, {'measure': 'Postoperative Liver function tests ie Bilirubin and albumin', 'timeFrame': 'at 12, 24, 72 hours and day 7 postoperatively'}, {'measure': 'Postoperative Liver function tests ie AST and ALT', 'timeFrame': 'at 12, 24, 72 hours and day 7 postoperatively'}, {'measure': 'Postoperative Liver function tests ie GGT', 'timeFrame': 'at 12, 24, 72 hours and day 7 postoperatively'}, {'measure': 'Postoperative Liver function tests ie platelet count', 'timeFrame': 'at 12, 24, 72 hours and day 7 postoperatively'}, {'measure': 'Postoperative coagulation profile', 'timeFrame': 'at 12, 24, 72 hours and day 7 postoperatively'}, {'measure': 'Postoperative Renal function tests i.e. Blood urea and S.creatinine levels', 'timeFrame': 'at12, 24, 72 hours and day7 postoperatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant Recipients']}, 'descriptionModule': {'briefSummary': 'Both isoflurane and propofol are being used to give anaesthesia for living donor liver transplant in our institute. Propofol when compared to isoflurane has advantages like early awakening from anaesthesia, reduced nausea, vomiting in the postoperative period. Propofol also has antioxidant properties. Because of its antioxidant properties propofol may have a protective effect against oxidative stress and ischemia reperfusion injury in major organs during liver transplant surgery. However, there are no studies showing the effect of isoflurane and propofol on Intraoperative hemodynamics and postoperative liver and kidney functions.Thus, we are conducting this study to know the effect of these agents on intraoperative hemodynamics and postoperative liver and kidney function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:-Above 18 years of age who will undergo living donor liver transplant\n\n\\-\n\nExclusion Criteria: Refusal to consent\n\n* Acute liver failure, Acute on chronic liver failure\n* Allergic to propofol or any component of propofol\n* Patients with pre existing cardiac dysfunction and cardiomyopathy\n* Patients with pre existing renal dysfunction/ deranged RFTs preoperatively'}, 'identificationModule': {'nctId': 'NCT06418893', 'briefTitle': 'Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Effect of Isoflurane and Target Control Infusion (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IEC/2023/100/MA05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isoflurane', 'description': 'Drug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period', 'interventionNames': ['Drug: Inhalational isoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol', 'description': 'Drug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period', 'interventionNames': ['Drug: Target control infusion propofol']}], 'interventions': [{'name': 'Target control infusion propofol', 'type': 'DRUG', 'description': 'target control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60', 'armGroupLabels': ['Propofol']}, {'name': 'Inhalational isoflurane', 'type': 'DRUG', 'description': 'Inhalational Isoflurane at concentration 1-2%', 'armGroupLabels': ['Isoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Abhinav Sharma, MD', 'role': 'CONTACT', 'email': 'abhi27sh@gmail.com', 'phone': '8860790151', 'phoneExt': '91'}], 'facility': 'Institute of liver and biliary sciences', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'centralContacts': [{'name': 'Abhinav Sharma, MD', 'role': 'CONTACT', 'email': 'abhi27sh@gmail.com', 'phone': '8860790151', 'phoneExt': '91'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Liver and Biliary Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}