Clinical trial NCT06418893: Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients.
Official title: Effect of Isoflurane and Target Control Infusion (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Liver Transplant Recipients
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
Collaborators: name: Institute of Liver and Biliary Sciences
First posted: 2024-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled, double blind
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:-Above 18 years of age who will undergo living donor liver transplant

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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

Primary outcomes:
measure: Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.
timeFrame: INTRAOPERATIVELY
Secondary outcomes:
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
Other outcomes:
Locations:
city: Delhi
country: India
facility: Institute of liver and biliary sciences
Study officials:
References: