Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.

Study Overview
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Brief Summary
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All consenting, adult patients aged 18 years and above who will require elective ventilation after liver transplant recipient surgery will be enrolled for the study. Patients in acute liver failure, hepatic encephalopathy or patients with history of allergic reactions to propofol will be excluded from the study. This is an observational study. As per institute treatment protocol, propofol will be given post-operatively at a dose of 1 mg/kg/hr and than titrated to maintain a Bi-Spectral Index (BIS) score of 60-80 till the patient is on ventilator. There will be no deviation from our routine institutional protocol and no other sedative drugs like opioids or benzodiazepines will be used and no interventions will be done. Hemodynamics will be maintained targeting a mean arterial pressure (MAP) of at least 65 mm Hg. during the study period using appropriate measures.

Official Title
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Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients-An Observational Study

Conditions
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Liver Cirrhoses

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Living donor liver transplant (LDLT) recipient adult patients ≥ 18 years of age requiring postoperative elective ventilation. Exclusion Criteria: Propofol allergy Acute liver failure (ALF). Hepatic encephalopathy (HE)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver transplant recipients<br>Adult patients requiring elective post-operative ventilation after a living donor liver transplant receiving intravenous propofol infusion for sedation titrated to Bi-Spectral Index (BIS) score of 60-80,as per our institutional protocol. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of propofol in mg/kg/hr required for sedation (BIS:60-80) of postoperative electively ventilated living donor liver transplant recipients. | Every 2 hrly , the continuous intravenous Propofol dose going on will be recorded. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of propofol dose over the study period to maintain BIS between 60 -80 | Propofol doses will be recorded titrated to BIS of 60-80 | up to 24 hours | 
| Correlation of the mean dose of propofol in mg/kg/hr with Arterial ammonia at baseline and to see the association between immediate post operative and Postoperative day1 ammonia with corresponding propofol dose. | Arterial ammonia levels will be noted pre-operatively, immediate post-operative and after extubation. | up to 24 hours | 
| Correlation of propofol dose with respective arterial lactate levels every 2 hours during the period of elective ventilation | Lactate levels will be recorded every 2 hrs till the patient is on ventilator | up to 24 hours |