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Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients.

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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06418893
Enrollment
60
Registered
2024-05-17
Start date
2023-08-01
Completion date
2024-10-31
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant Recipients

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.

Interventions

DRUGTarget control infusion propofol

target control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60

Inhalational Isoflurane at concentration 1-2%

Sponsors

Institute of Liver and Biliary Sciences
CollaboratorUNKNOWN
Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Randomised, controlled, double blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.INTRAOPERATIVELYTCI propofol will provide more stable hemodynamics

Secondary

MeasureTime frame
To compare between the two groups mean systemic vascular resistance during different phases of liver transplant recorded every 15 minutesINTRAOPERATIVELY AT 15 MINUTES INTERVAL
To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutesINTRAOPERATIVELY AT 15 MINUTES INTERVAL
Total vasopressor requirement during reperfusionIntraoperative
Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperativelyIntraoperatively
QTc interval between the two groups during different phases of liver transplant measured every 15 minutesIntraoperatively every 15 mins
Peak lactate levels intraoperativelyIntraoperatively
To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutesINTRAOPERATIVELY AT 15 MINUTES INTERVAL
Postoperative Liver function tests ie AST and ALTat 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie GGTat 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie platelet countat 12, 24, 72 hours and day 7 postoperatively
Postoperative coagulation profileat 12, 24, 72 hours and day 7 postoperatively
Postoperative Renal function tests i.e. Blood urea and S.creatinine levelsat12, 24, 72 hours and day7 postoperatively
Postoperative Liver function tests ie Bilirubin and albuminat 12, 24, 72 hours and day 7 postoperatively

Countries

India

Contacts

Primary ContactAbhinav Sharma, MD
abhi27sh@gmail.com8860790151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026