Clinical trial

Effect of Isoflurane and Target Control Infusion (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients: A Randomized Controlled Trial.

Name
IEC/2023/100/MA05
Description
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.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-10-01
Trial end
2024-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Target control infusion propofol
target control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60
Arms:
Propofol
Inhalational isoflurane
Inhalational Isoflurane at concentration 1-2%
Arms:
Isoflurane
Size
60
Primary endpoint
Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.
INTRAOPERATIVELY
Eligibility criteria
Inclusion Criteria:-Above 18 years of age who will undergo living donor liver transplant - Exclusion Criteria: Refusal to consent * Acute liver failure, Acute on chronic liver failure * Allergic to propofol or any component of propofol * Patients with pre existing cardiac dysfunction and cardiomyopathy * Patients with pre existing renal dysfunction/ deranged RFTs preoperatively
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, controlled, double blind', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-05-17

1 organization

2 products

1 indication

Product
Propofol
Product
Isoflurane