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.

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 Overview

• Status: Recruiting
• Conditions: Liver Transplant Recipients
• Intervention / Treatment: Drug: Inhalational isoflurane; Drug: Target control infusion propofol

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Abhinav Sharma, MD; Phone Number: 91 8860790151; Email: abhi27sh@gmail.com

Study Locations

• India
  • Delhi, India, 110070
    • Recruiting
    • Institute of Liver and Biliary Sciences
    • Contact: Abhinav Sharma, MD; Phone Number: 91 8860790151; Email: abhi27sh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Isoflurane; Drug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period	Drug: Inhalational isoflurane; Inhalational Isoflurane at concentration 1-2%
Experimental: Propofol; Drug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period	Drug: Target control infusion propofol; target control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.	TCI propofol will provide more stable hemodynamics	INTRAOPERATIVELY

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes	INTRAOPERATIVELY AT 15 MINUTES INTERVAL
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
To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes	INTRAOPERATIVELY AT 15 MINUTES INTERVAL
Total vasopressor requirement during reperfusion	Intraoperative
Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively	Intraoperatively
QTc interval between the two groups during different phases of liver transplant measured every 15 minutes	Intraoperatively every 15 mins
Peak lactate levels intraoperatively	Intraoperatively
Postoperative Liver function tests ie Bilirubin and albumin	at 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie AST and ALT	at 12, 24, 72 hours and day 7 postoperatively
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
Postoperative coagulation profile	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Collaborators: Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Isoflurane
• Other Study ID Numbers: IEC/2023/100/MA05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No