Propofol for Sedation of Postoperative Electively Ventilated Liver Transplant Recipients.

NCT ID: NCT03837145

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-12

Study Completion Date

2019-03-31

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.

Detailed Description

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Conditions

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Liver Cirrhoses

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Rishabh Jaju

senior resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rishabh jaju, DNB

Role: PRINCIPAL_INVESTIGATOR

Institute of liver and biliary sciences,New Delhi-110070

Locations

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Institute of liver and biliary sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rishabh jaju, DNB

Role: CONTACT

7742454477

Kelika Prakash, DM

Role: CONTACT

9540947117

Facility Contacts

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rishabh jaju, DNB

Role: primary

7742454477

kelika prakash, DM

Role: backup

9540947117

Other Identifiers

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ILBS-TRANSPLANT ANESTHESIA-01

Identifier Type: -

Identifier Source: org_study_id

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