Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhoses

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver and Biliary Sciences
      • Contact: rishabh jaju, DNB; Phone Number: 7742454477; Email: rishabh.cares@gmail.com
      • Contact: kelika prakash, DM; Phone Number: 9540947117; Email: kelika.prakash@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consenting LDLT recipient adult patients ≥ 18 years of age who require postoperative elective ventilation after recieving a living donor liver transplant.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Liver transplant recipients; 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?

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: rishabh jaju, DNB, Institute of liver and biliary sciences,New Delhi-110070

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2019
• Primary Completion (ANTICIPATED): March 31, 2019
• Study Completion (ANTICIPATED): March 31, 2019

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (ACTUAL): February 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-TRANSPLANT ANESTHESIA-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No