Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.

Liver Cirrhoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837145
• Other study ID #: ILBS-TRANSPLANT ANESTHESIA-01
• Status: Recruiting
• Start date: January 12, 2019
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Rishabh jaju, DNB
• Phone: 7742454477
• Email: rishabh.cares[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Liver Cirrhoses
• Liver Cirrhosis

Locations

Country	Name	City	State
India	Institute of liver and biliary sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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