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

Liver Transplant Recipients Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418893
• Other study ID #: IEC/2023/100/MA05
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Abhinav Sharma, MD
• Phone: 8860790151
• Email: abhi27sh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant Recipients

Intervention

Drug:
• Target control infusion propofol
target control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60
• Inhalational isoflurane
Inhalational Isoflurane at concentration 1-2%

Locations

Country	Name	City	State
India	Institute of liver and biliary sciences	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India	Institute of Liver and Biliary Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes		INTRAOPERATIVELY AT 15 MINUTES INTERVAL
Secondary	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
Secondary	To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes		INTRAOPERATIVELY AT 15 MINUTES INTERVAL
Secondary	Total vasopressor requirement during reperfusion		Intraoperative
Secondary	Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively		Intraoperatively
Secondary	QTc interval between the two groups during different phases of liver transplant measured every 15 minutes		Intraoperatively every 15 mins
Secondary	Peak lactate levels intraoperatively		Intraoperatively
Secondary	Postoperative Liver function tests ie Bilirubin and albumin		at 12, 24, 72 hours and day 7 postoperatively
Secondary	Postoperative Liver function tests ie AST and ALT		at 12, 24, 72 hours and day 7 postoperatively
Secondary	Postoperative Liver function tests ie GGT		at 12, 24, 72 hours and day 7 postoperatively
Secondary	Postoperative Liver function tests ie platelet count		at 12, 24, 72 hours and day 7 postoperatively
Secondary	Postoperative coagulation profile		at 12, 24, 72 hours and day 7 postoperatively
Secondary	Postoperative Renal function tests i.e. Blood urea and S.creatinine levels		at12, 24, 72 hours and day7 postoperatively