Effect of Isoflurane and Target Control Infusion (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Isoflurane
Drug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period
Intervention: Inhalational isoflurane (Drug)
Propofol
Drug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period
Intervention: Target control infusion propofol (Drug)
Outcomes
Primary Outcomes
Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.
Time Frame: INTRAOPERATIVELY
TCI propofol will provide more stable hemodynamics
Secondary Outcomes
- To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes(INTRAOPERATIVELY AT 15 MINUTES INTERVAL)
- Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively(Intraoperatively)
- Postoperative Liver function tests ie Bilirubin and albumin(at 12, 24, 72 hours and day 7 postoperatively)
- Total vasopressor requirement during reperfusion(Intraoperative)
- Postoperative Liver function tests ie GGT(at 12, 24, 72 hours and day 7 postoperatively)
- Postoperative Liver function tests ie platelet count(at 12, 24, 72 hours and day 7 postoperatively)
- To compare between the two groups mean systemic vascular resistance during different phases of liver transplant recorded every 15 minutes(INTRAOPERATIVELY AT 15 MINUTES INTERVAL)
- QTc interval between the two groups during different phases of liver transplant measured every 15 minutes(Intraoperatively every 15 mins)
- Postoperative coagulation profile(at 12, 24, 72 hours and day 7 postoperatively)
- To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes(INTRAOPERATIVELY AT 15 MINUTES INTERVAL)
- Postoperative Liver function tests ie AST and ALT(at 12, 24, 72 hours and day 7 postoperatively)
- Postoperative Renal function tests i.e. Blood urea and S.creatinine levels(at12, 24, 72 hours and day7 postoperatively)
- Peak lactate levels intraoperatively(Intraoperatively)