| CTRI Number |
CTRI/2024/12/078700 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study checked how two anesthesia drugs, Desflurane and Propofol, affect liver healing and damage from blood flow changes during liver transplant surgery. |
|
Scientific Title of Study
|
Comparison of the effect of Desflurane versus total intravenous anesthesia with Propofol on ischemia reperfusion injury and liver regeneration in liver transplant recipients - A randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kondaveeti Anusha |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anaesthesiology, ILBS, D1, Sector D, Vasant Kunj, New Delhi, India
South West
DELHI
110070
India |
| Phone |
9491213659 |
| Fax |
|
| Email |
anookondaveeti999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gaurav Sindwani |
| Designation |
Associate professor |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anaesthesiology, ILBS, D1, Sector D, Vasant Kunj, New Delhi, India
South West
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kondaveeti Anusha |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anaesthesiology, ILBS, D1, Sector D, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9491213659 |
| Fax |
|
| Email |
anookondaveeti999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of liver and biliary sciences |
| Address |
D1, sector D, Vasant Kunj, New Delhi, India,110070, Country code: 91 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kondaveeti Anusha |
Department of Anaesthesiology, Institute of liver and biliary sciences |
ILBS, D1, Sector D, Vasant Kunj, New Delhi
South West
DELHI |
9491213659
anookondaveeti999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of liver and biliary sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K721||Chronic hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anaesthesia |
Propofol and Desflurane |
| Intervention |
General anaesthesia |
Propofol total intravenous anaesthesia with BIS maintained between 40-60 range, and Inhalationl anaesthesia with Desflurane with MAC 0.8-1.2 range are compared. Total duration of anesthesia is throughout the surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective living donor liver transplantation for chronic liver disease
Agrees to participate in research
Age 18-65 years
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Desflurane is comparable to TIVA with Propofol in preventing hepatocyte ischemia-reperfusion injury and promoting hepatic regeneration.
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the serum levels of liver regeneration markers [hepatocyte growth factor(HGF), Vascular enndothelial growth factor(VEGF)] during baseline, POD 1 and 7
Comparison of the incidence of ischemia reperfusion injury using the serum levels of markers CK 8/18, VWF, IL-6, IL-1β, TNF-α, HMGB-1, mtDNA, LDH, lactic acid during baseline, immediate post-reperfusion(30min-1hr), early post-reperfusion(6h-12h), early postoperative period(24h-48h).
To compare the incidence and severity of post reperfusion syndrome
To compare the liver function tests (Sr. Bilirubin, AST, ALT, GGT, albumin, platelet count, prothrombin time, INR, lactate) during baseline, POD 1 to 7
|
7 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Orthotopic liver transplantation is the definitive treatment for end-stage liver disease. Donor hepatectomy is performed on healthy individuals with minimal comorbidities. The type of anesthesia used, along with cold and warm ischemia times and dissection duration, significantly impacts liver regeneration and postoperative function.
Hepatocytes typically proliferate in response to stimuli like toxic injury or surgery. After hepatectomy, the remaining liver enlarges to restore normal mass and function, usually within 10 days. This process begins with an acute phase response, activating cytokines such as TNF-α and IL-6, which prompt hepatocytes to enter the cell cycle. Growth factors like HGF and VEGF then facilitate the progression of liver regeneration.
Hepatic ischemia-reperfusion injury (IRI) involves inflammation, free radical production, and mitochondrial damage. Protective strategies against IRI include both surgical and pharmacologic interventions aimed at minimizing cellular injury during reperfusion.
Desflurane, a fluorine-containing volatile anesthetic, is commonly used in liver transplantation due to its minimal impact on liver function and real-time concentration monitoring. It offers hepatoprotection by inhibiting NF-κB activation and reducing inflammatory factors, leading to lower post-transplant serum ALT and TB levels.
Propofol, an intravenous anesthetic with antioxidant properties, has also shown potential in reducing oxidative stress and IRI. It may contribute to liver regeneration by reducing apoptosis and promoting cell proliferation.
This study aims to compare the effects of desflurane and propofol on ischemia-reperfusion injury and liver regeneration during orthotopic liver transplantation, from donor dissection through recipient transplantation.
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