The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Aretaieio Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aretaieio Hospital
ClinicalTrials.gov Identifier:
NCT01267786
First received: December 28, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic function after ischemic/reperfusion injury and the sequence influence on renal and cardiovascular systems.


Condition Intervention Phase
Apoptosis
Liver Surgery
Procedure: Liver surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery

Resource links provided by NLM:


Further study details as provided by Aretaieio Hospital:

Primary Outcome Measures:
  • Oxidotic stress after hepatectomy. [ Time Frame: 5 d postop. ] [ Designated as safety issue: Yes ]
    Perioperative liver and renal biopsies and follow up with liver renal function tests plus intraoperative and postoperative cardiovascular monitoring


Secondary Outcome Measures:
  • Liver and renal dysfunction [ Time Frame: 5 d ] [ Designated as safety issue: Yes ]
    liver and renal impairment due to ischemic injury


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sevoflurane
1MAC intraoperatively
Procedure: Liver surgery
hepatectomy
Active Comparator: desflurane
1 MAC intraoperatively
Procedure: Liver surgery
hepatectomy

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing liver surgery

Exclusion Criteria:

  • ASA IV, Cardiovascular diseases
  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: NCT01267786

Contacts
Contact: Georgios P Fragulidis, MD +30 6072910955 gfragulidis@aretaieio.uoa.gr
Contact: Aikaterini D Melemeni, MD, DESA +30 6946194817 amelemeni@med.uoa.gr

Locations
Greece
Aretaieio Hospital Recruiting
Athens, Attica, Greece, 115 28
Principal Investigator: Georgios P Fragulidis, MD         
Sponsors and Collaborators
Aretaieio Hospital
Investigators
Principal Investigator: Georgios P Fragulidis, MD Areataieio Hospital
  More Information

No publications provided

Responsible Party: G.P. Fragulidis MD, Ass. Prof. Surgery, University of Athens
ClinicalTrials.gov Identifier: NCT01267786     History of Changes
Other Study ID Numbers: AnesthSurg1
Study First Received: December 28, 2010
Last Updated: December 28, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by Aretaieio Hospital:
Oxidotic stress

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

ClinicalTrials.gov processed this record on July 29, 2014