## Protocol Section
### Identification Module
**NCT ID:** NCT06418893

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

**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.

#### Organization Study ID Info
**ID:** IEC/2023/100/MA05
#### Organization
**Class:** OTHER
**Full Name:** Institute of Liver and Biliary Sciences, India
### Status Module
#### Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-08-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-17
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Institute of Liver and Biliary Sciences

#### Lead Sponsor

**Class:** OTHER

**Name:** Institute of Liver and Biliary Sciences, India

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Liver Transplant Recipients

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomised, controlled, double blind

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Inhalational isoflurane

**Label:** Isoflurane

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Drug: Target control infusion propofol

**Label:** Propofol

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Propofol

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

**Name:** Target control infusion propofol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Isoflurane

**Description:** Inhalational Isoflurane at concentration 1-2%

**Name:** Inhalational isoflurane

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** TCI propofol will provide more stable hemodynamics

**Measure:** Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.

**Time Frame:** INTRAOPERATIVELY

#### Secondary Outcomes

**Measure:** To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes

**Time Frame:** INTRAOPERATIVELY AT 15 MINUTES INTERVAL

**Measure:** To compare between the two groups mean systemic vascular resistance during different phases of liver transplant recorded every 15 minutes

**Time Frame:** INTRAOPERATIVELY AT 15 MINUTES INTERVAL

**Measure:** To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes

**Time Frame:** INTRAOPERATIVELY AT 15 MINUTES INTERVAL

**Measure:** Total vasopressor requirement during reperfusion

**Time Frame:** Intraoperative

**Measure:** Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively

**Time Frame:** Intraoperatively

**Measure:** QTc interval between the two groups during different phases of liver transplant measured every 15 minutes

**Time Frame:** Intraoperatively every 15 mins

**Measure:** Peak lactate levels intraoperatively

**Time Frame:** Intraoperatively

**Measure:** Postoperative Liver function tests ie Bilirubin and albumin

**Time Frame:** at 12, 24, 72 hours and day 7 postoperatively

**Measure:** Postoperative Liver function tests ie AST and ALT

**Time Frame:** at 12, 24, 72 hours and day 7 postoperatively

**Measure:** Postoperative Liver function tests ie GGT

**Time Frame:** at 12, 24, 72 hours and day 7 postoperatively

**Measure:** Postoperative Liver function tests ie platelet count

**Time Frame:** at 12, 24, 72 hours and day 7 postoperatively

**Measure:** Postoperative coagulation profile

**Time Frame:** at 12, 24, 72 hours and day 7 postoperatively

**Measure:** Postoperative Renal function tests i.e. Blood urea and S.creatinine levels

**Time Frame:** at12, 24, 72 hours and day7 postoperatively

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** abhi27sh@gmail.com

**Name:** Abhinav Sharma, MD

**Phone:** 8860790151

**Phone Ext:** 91

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Delhi

**Contacts:**

***Contact 1:***

- **Email:** abhi27sh@gmail.com

- **Name:** Abhinav Sharma, MD

- **Phone:** 8860790151

- **Phone Ext:** 91

- **Role:** CONTACT

**Country:** India

**Facility:** Institute of liver and biliary sciences

**Status:** RECRUITING

**Zip:** 110070

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000018685

- Term: Anesthetics, Inhalation

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

### Intervention Browse Module - Browse Leaves

- ID: M18307

- Name: Propofol

- Relevance: HIGH

- As Found: Symptoms

- ID: M10562

- Name: Isoflurane

- Relevance: HIGH

- As Found: Bismuth

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M20765

- Name: Anesthetics, Inhalation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000015742

- Term: Propofol

- ID: D000007530

- Term: Isoflurane

### Misc Info Module

- Version Holder: 2024-05-31
