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Validation of the Bispectral Index Monitor During Living Donor Liver Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01494220
First received: December 13, 2011
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  Purpose

Bispectral index (BIS) monitoring during living donor liver transplantation (LDLT) may be influenced with several factors rather than the depth of anesthesia such as bradycardia, hypotension, hypothermia, and mixed venous oxygen saturation (SvO2). The investigators tested the validity and the independent factors which may alter of BIS readings during LDLT.

Up to the investigators best knowledge, the independent predictors for BIS monitoring were not identified yet during the three phases of liver transplantation.


Condition Intervention
Liver Cirrhosis
 Device: Bispectral index monitoring (BIS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Bispectral Index Monitor During Living Donor Liver Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Intraoperative blood loss [ Time Frame: up to 1 hr after surgery ] [ Designated as safety issue: No ]
    Intraoperative blood loss

  • Changes from Baseline in hemodynamic variables [ Time Frame: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases ] [ Designated as safety issue: No ]
    Hemodynamic changes

  • Changes from Baseline in Temperature variables [ Time Frame: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases ] [ Designated as safety issue: No ]
    Temperature

  • Changes in blood gases variables from baseline [ Time Frame: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases ] [ Designated as safety issue: No ]
    Blood gases


Secondary Outcome Measures:
  • postoperative liver function tests [ Time Frame: up to 6 hrs after surgery ] [ Designated as safety issue: No ]
    correlation between BIS values and postoperative liver function tests

  • postoperative coagulation factors [ Time Frame: up to 6 hrs after surgery ] [ Designated as safety issue: No ]
    correlation between BIS and postoperative coagulation factors

  • 3-months mortality [ Time Frame: up to 3 months after surgery ] [ Designated as safety issue: No ]
    correlation between BIS values and 3-months mortality


Enrollment: 42
Study Start Date: June 2007
Study Completion Date: February 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Living donor liver transplantation
Patients undergoing living donor liver transplantation in the Mansoura University Liver Transplantation Program from 2007 to 2010
 Device: Bispectral index monitoring (BIS)
BIS recording electrodes (Aspect Medical Systems. Inc., One Upland Road, Norwood, MA 02062 USA) were applied to the forehead of each patient according to the manufacturer recommendations. The BIS monitor was masked with opaque sheet and BIS data was recorded prior to induction of general anesthesia then continued throughout the procedure. All information obtained from the BIS monitor was continuously downloaded to a computer for offline analysis. The patient's management was not guided by the changes in BIS readings.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mansoura University Liver Transplantation Program

Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical class III-IV
  • aged 20-50 years
  • severe liver dysfunction
  • Child-Pugh Class C
  • liver cirrhosis

Exclusion Criteria:

  • preexisting significant neuropsychiatric
  • cardiac diseases
  • pulmonary diseases
  • renal diseases
  • neuromuscular diseases
  • electrolyte disorders
  • body mass index greater than 35 kg/m2
  • pregnancy
  • use of antipsychotics
  • use of antidepressants
  • alcohol abuse
  • drug abuse
  • previous transplantation
  • those with hepatic encephalopathy
  • recent cognitive dysfunction during the past three months
  • fulminant hepatic failure
  • hepato-pulmonary syndrome
  • pulmonary hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494220

Locations
Egypt
College of Medicine, Mansoura University
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
Study Director: Mohamed R El Tahan, MD Anesthesiology Department, Principal Investigator, Clinical Associate Professor
  More Information

No publications provided

Responsible Party: Mohamed R El Tahan, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT01494220     History of Changes
Other Study ID Numbers: 2007-5, Liver Transplantation Unit 3
Study First Received: December 13, 2011
Last Updated: April 3, 2012
Health Authority: Egypt: Medical Research & Ethics Committee of Mansoura University

Keywords provided by Mansoura University:
Bispectral index; anesthesia
liver transplantation
independent factors
outcome
Living donor liver transplantation

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013