Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.

NCT03837145 | Unknown

• 1 other identifier: ILBS-TRANSPLANT ANESTHESIA-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhoses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes of propofol dose over the study period to maintain BIS between 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.

  up to 24 hours

• Correlation of propofol dose with respective arterial lactate levels every 2 hours during the period of elective ventilation

  up to 24 hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Living donor liver transplant (LDLT) recipient adult patients ≥ 18 years of age requiring postoperative elective ventilation.

You may not qualify if:

• Propofol allergy
• Acute liver failure (ALF).
• Hepatic encephalopathy (HE)

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and biliary sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Study Officials

• rishabh jaju, DNB

  Institute of liver and biliary sciences,New Delhi-110070

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rishabh jaju, DNB

CONTACT

7742454477; rishabh.cares@gmail.com

Kelika Prakash, DM

CONTACT

9540947117; kelika.prakash@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior resident

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 12, 2019
• Study Start: January 12, 2019
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

IN (1)