Isoflurane Preconditioning for Liver Resections

This study has been terminated.
(We no longer had an appropriate patient population.Study closed)
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01031550
First received: December 10, 2009
Last updated: September 30, 2016
Last verified: December 2013
  Purpose
The objective is to examine the efficacy of isoflurane (inhaled anesthetic gas) to induce clinically effective preconditioning in patients undergoing elective hepatic surgery.

Condition Intervention
Liver Disease
Drug: isoflurane
Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isoflurane Induced Anesthetic Preconditioning in Elective Liver Resection

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Post Operative Complications Grade IIIb or Greater According to Clavien's Classification Which is a Classification System Used to Grade Surgical Complications [ Time Frame: first 7 post operative days ]
    Post operative complications grade IIIB or greater according to Clavien's classification: IIIb=complication necessitating an intervention under general anesthesia; Grade IV=Life threatening complications requiring ICU management, IV a =single organ dysfunction, IVb=multi-organ dysfunction; V=death Suffix d(disability)=subject suffers from complication at time of discharge. This label indicates the need for a follow up to fully evaluate the complication.


Secondary Outcome Measures:
  • Peak Postoperative AST, ALT and T Bili [ Time Frame: first 7 post operative days ]
  • Length of ICU and Hospital Stay [ Time Frame: first 7 post operative days ]
  • Decrease in Liver Lipid Peroxidation and Apoptosis [ Time Frame: first 7 post operative days ]

Enrollment: 8
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard anesthetic management
standard anesthetic management with propofol 100-150mcg/kg/min
Drug: propofol
standard of care
Other Name: diprivan
Experimental: preconditioning with 2 MAC isoflurane group
After induction, anesthesia will be maintained with 1MAC (minimum alveolar concentration) of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
Drug: isoflurane
isoflurane an anesthetic gas agent administered at specific times at a flow of 2 MAC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with liver tumors undergoing liver resection of > 1 segment liver resection must be performed with inflow occlusion > 30 min

Exclusion Criteria:

  • patients undergoing liver resection of one segment or less
  • patients undergoing laparoscopic liver resection
  • patients in whom the liver resection is performed with no inflow occlusion or inflow occlusion of < 30 min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031550

Locations
United States, New Jersey
UMDNJ-University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Yuriy Gubenko, MD Rutgers, The State University of New Jersey
  More Information

Responsible Party: Anesthesia, Investigator Intiated Dept of Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01031550     History of Changes
Other Study ID Numbers: 0120090226 
Study First Received: December 10, 2009
Results First Received: September 16, 2013
Last Updated: September 30, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Rutgers, The State University of New Jersey:
liver resection for liver disease

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Propofol
Anesthetics
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on January 19, 2017