Isoflurane Preconditioning for Liver Resections

NCT01031550 | Terminated Results

• 1 other identifier: 0120090226
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Disease

Keywords

liver resection for liver disease

Outcome Measures

Primary Outcomes (1)

• Post Operative Complications Grade IIIb or Greater According to Clavien's Classification Which is a Classification System Used to Grade Surgical Complications

  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.

  first 7 post operative days

Secondary Outcomes (3)

• Peak Postoperative AST, ALT and T Bili

  first 7 post operative days

• Length of ICU and Hospital Stay

  first 7 post operative days

• Decrease in Liver Lipid Peroxidation and Apoptosis

  first 7 post operative days

Study Arms (2)

standard anesthetic management

ACTIVE COMPARATOR

standard anesthetic management with propofol 100-150mcg/kg/min

Drug: propofol

preconditioning with 2 MAC isoflurane group

EXPERIMENTAL

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

Interventions

isoflurane DRUG

isoflurane an anesthetic gas agent administered at specific times at a flow of 2 MAC

preconditioning with 2 MAC isoflurane group

propofol DRUG

standard of care

Also known as: diprivan

standard anesthetic management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

UMDNJ-University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Isoflurane; Propofol

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Due to termination of the study no data analysis was performed.

Results Point of Contact

• Title: Yuriy Gubenko, MD
• Organization: UMDNJ

yuriygubenko@yahoo.com

973 972-5007

Study Officials

• Yuriy Gubenko, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Intiated Dept of Anesthesia

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 20, 2017
• Results First Posted: December 12, 2013

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)