We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Isoflurane Preconditioning for Liver Resections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01031550
Recruitment Status : Terminated (We no longer had an appropriate patient population.Study closed)
First Posted : December 14, 2009
Results First Posted : December 12, 2013
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Yuriy Gubenko, MD, Rutgers, The State University of New Jersey

Brief Summary:
The objective is to examine the efficacy of isoflurane (inhaled anesthetic gas) to induce clinically effective preconditioning in patients undergoing elective hepatic surgery.

Condition or disease Intervention/treatment
Liver Disease Drug: isoflurane Drug: propofol

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isoflurane Induced Anesthetic Preconditioning in Elective Liver Resection
Study Start Date : January 2010
Primary Completion Date : January 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Peak Postoperative AST, ALT and T Bili [ Time Frame: first 7 post operative days ]
  2. Length of ICU and Hospital Stay [ Time Frame: first 7 post operative days ]
  3. Decrease in Liver Lipid Peroxidation and Apoptosis [ Time Frame: first 7 post operative days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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): 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

Responsible Party: Yuriy Gubenko, MD, Investigator Intiated Dept of Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01031550     History of Changes
Other Study ID Numbers: 0120090226
First Posted: December 14, 2009    Key Record Dates
Results First Posted: December 12, 2013
Last Update Posted: March 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yuriy Gubenko, MD, 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