Liver Transplant RecipientsPhase 2/3NCT06418893
Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients.
A Phase 2/3 study testing Inhalational isoflurane in people with Liver Transplant Recipients, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Transplant Recipients
- What is being tested?
- Inhalational isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to 31 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of liver and biliary sciences
Delhi, 110070
Abhinav Sharma, MD, 8860790151 ext. 91, abhi27sh@gmail.com
About this study
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.
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
- Being tested
- Target control infusion propofol, Inhalational isoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target control infusion propofolDrug
target control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60
Inhalational isofluraneDrug
Inhalational Isoflurane at concentration 1-2%
| Study group | Role | What they receive |
|---|---|---|
| Isoflurane | Active comparator | Drug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period Receives: Drug: Inhalational isoflurane |
| Propofol | Experimental | Drug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period Receives: Drug: Target control infusion propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: INTRAOPERATIVELY
Secondary outcomes (13)
To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes
Measured: 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
Measured: INTRAOPERATIVELY AT 15 MINUTES INTERVAL
To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes
Measured: INTRAOPERATIVELY AT 15 MINUTES INTERVAL
Total vasopressor requirement during reperfusion
Measured: Intraoperative
Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively
Measured: Intraoperatively
QTc interval between the two groups during different phases of liver transplant measured every 15 minutes
Measured: Intraoperatively every 15 mins
Peak lactate levels intraoperatively
Measured: Intraoperatively
Postoperative Liver function tests ie Bilirubin and albumin
Measured: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie AST and ALT
Measured: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie GGT
Measured: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie platelet count
Measured: at 12, 24, 72 hours and day 7 postoperatively
Postoperative coagulation profile
Measured: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Renal function tests i.e. Blood urea and S.creatinine levels
Measured: at12, 24, 72 hours and day7 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Aug 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, double blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418893
- Sponsor's protocol ID
- IEC/2023/100/MA05
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06418893
- Acronym / sponsor ID
- IEC/2023/100/MA05
- Conditions
- Liver Transplant Recipients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, controlled, double blind
| Arm | Type | Receives |
|---|---|---|
| Isoflurane | Active comparator | Drug: Inhalational isofluraneDrug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period |
| Propofol | Experimental | Drug: Target control infusion propofolDrug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target control infusion propofoltarget control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60 | Drug | Propofol |
| Inhalational isofluraneInhalational Isoflurane at concentration 1-2% | Drug | Isoflurane |
Primary outcome
Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.
Time frame: INTRAOPERATIVELY
TCI propofol will provide more stable hemodynamics
13 secondary outcomes
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
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
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
Total vasopressor requirement during reperfusion
Time frame: Intraoperative
Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively
Time frame: Intraoperatively
QTc interval between the two groups during different phases of liver transplant measured every 15 minutes
Time frame: Intraoperatively every 15 mins
Peak lactate levels intraoperatively
Time frame: Intraoperatively
Postoperative Liver function tests ie Bilirubin and albumin
Time frame: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie AST and ALT
Time frame: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie GGT
Time frame: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Liver function tests ie platelet count
Time frame: at 12, 24, 72 hours and day 7 postoperatively
Postoperative coagulation profile
Time frame: at 12, 24, 72 hours and day 7 postoperatively
Postoperative Renal function tests i.e. Blood urea and S.creatinine levels
Time frame: at12, 24, 72 hours and day7 postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Inhalational isoflurane in people with Liver Transplant Recipients, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abhinav Sharma, MD (8860790151 ext. 91, abhi27sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively. (time frame: INTRAOPERATIVELY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.