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Organ Protection With Sevoflurane Postconditioning

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00518908
First received: August 20, 2007
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

Organ protection, volatile anesthetics, postconditioning, hepatic surgery


Condition Intervention
Hepatectomy
 Drug: Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion: Postconditioning

Resource links provided by NLM:

Drug Information available for: Sevoflurane
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Liver transaminase AST [ Time Frame: Postoperative phase until discharge ] [ Designated as safety issue: No ]
    Peak value


Secondary Outcome Measures:
  • ALT peak value [ Time Frame: Postoperative phase until discharge ] [ Designated as safety issue: No ]
  • Course of transaminases [ Time Frame: From the day before surgery, to 6 hours after surgery, up to postoperative day 7 ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: Postoperative phase until discharge ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: Postoperative phase until discharge ] [ Designated as safety issue: No ]
  • Need for prolonged intensive care unit stay (>24 hours) [ Time Frame: Postoperative phase until discharge ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sevoflurane
Sevoflurane for pharmacological postconditioning
 Drug: Sevoflurane
3.2 Vol % for postconditioning
Experimental: Propofol
Anesthesia maintenance with propofol instead of Sevoflurane postconditioning
 Drug: Sevoflurane
3.2 Vol % for postconditioning

Detailed Description:

This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • older than 18 years
  • patients undergoing liver resection (benign or malignant tumors)

Exclusion criteria:

  • non-german speakers
  • laparoscopic liver resection
  • coagulopathy (platelets < 50'000/ml, Quick < 50%)
  • liver cirrhosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518908

Locations
Switzerland
University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: BECK SCHIMMER Beatrice, Professor, University Hospital Zurich, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00518908     History of Changes
Other Study ID Numbers: StV 34-2007
Study First Received: August 20, 2007
Last Updated: July 18, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Ischemia reperfusion injury
Organ protection

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013