Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.

• Conditions: Liver Cirrhoses

• Registration Number: NCT03837145
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-12
• Study First Submitted: 2019-01-29
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-06
• Last Update Submitted: 2019-02-06
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation of propofol dose with respective arterial lactate levels every 2 hours during the period of elective ventilation	up to 24 hours	Lactate levels will be recorded every 2 hrs till the patient is on ventilator
Changes of propofol dose over the study period to maintain BIS between 60 -80	up to 24 hours	Propofol doses will be recorded titrated to BIS of 60-80
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.	up to 24 hours	Arterial ammonia levels will be noted pre-operatively, immediate post-operative and after extubation.

Trial Locations

Locations (1)

Institute of liver and biliary sciences; 🇮🇳 New Delhi, Delhi, India