Validation of the Bispectral Index Monitor During Living Donor Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT01494220|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : April 4, 2012
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 or disease||Intervention/treatment|
|Liver Cirrhosis||Device: Bispectral index monitoring (BIS)|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|Official Title:||Validation of the Bispectral Index Monitor During Living Donor Liver Transplantation|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||February 2011|
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.
- Intraoperative blood loss [ Time Frame: up to 1 hr after surgery ]Intraoperative blood loss
- Changes from Baseline in hemodynamic variables [ Time Frame: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases ]Hemodynamic changes
- Changes from Baseline in Temperature variables [ Time Frame: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases ]Temperature
- Changes in blood gases variables from baseline [ Time Frame: 30 min during hepatectomy, 30 min during anhepatic, 30 min during neohepatic phases ]Blood gases
- postoperative liver function tests [ Time Frame: up to 6 hrs after surgery ]correlation between BIS values and postoperative liver function tests
- postoperative coagulation factors [ Time Frame: up to 6 hrs after surgery ]correlation between BIS and postoperative coagulation factors
- 3-months mortality [ Time Frame: up to 3 months after surgery ]correlation between BIS values and 3-months mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494220
|College of Medicine, Mansoura University|
|Mansoura, DK, Egypt, 050|
|Study Director:||Mohamed R El Tahan, MD||Anesthesiology Department, Principal Investigator, Clinical Associate Professor|