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

NCT06418893 | Recruiting Phase 2 DMC

• 1 other identifier: IEC/2023/100/MA05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (2)

Isoflurane

ACTIVE COMPARATOR

Drug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period

Drug: Inhalational isoflurane

Propofol

EXPERIMENTAL

Drug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period

Drug: Target control infusion propofol

Interventions

Target control infusion propofol DRUG

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

Propofol

Inhalational isoflurane DRUG

Inhalational Isoflurane at concentration 1-2%

Isoflurane

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead
• Institute of Liver and Biliary Sciences: collaborator

Study Sites (1)

Institute of liver and biliary sciences

Delhi, 110070, India

RECRUITING

Central Study Contacts

Abhinav Sharma, MD

CONTACT

8860790151; abhi27sh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, double blind

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 17, 2024
• Study Start: August 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 31, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)