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Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 23, 2013
Last Update Posted: April 7, 2016
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.
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute
This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.

Condition Intervention
Microsurgical Free Flaps Drug: Balanced anesthesia Drug: Total intravenous anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Ester Forastiere, Regina Elena Cancer Institute:

Primary Outcome Measures:
  • continuous tissue oximetry (NIRS) [ Time Frame: 20 hours ]

Secondary Outcome Measures:
  • Biochemical Markers [ Time Frame: Preoperative and 24 hours post operative ]
  • Lactate Clearance [ Time Frame: 24 hours ]

Enrollment: 132
Study Start Date: February 2013
Study Completion Date: February 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total intravenous anesthesia
Total intravenous anaesthesia
Drug: Total intravenous anesthesia
Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion
Other Name: TIVA-TCI
Experimental: Balanced anesthesia Drug: Balanced anesthesia
Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml
Other Name: Inhalation anesthesia


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II

Exclusion Criteria:

Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease

  Contacts and Locations
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): NCT01905501

Regina Elena CI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
Principal Investigator: Ester Forastiere, M.D. Regina Elena CI
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ester Forastiere, M.D., Chief of Critical Area Department, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT01905501     History of Changes
Other Study ID Numbers: Versione 02.01.2013
First Submitted: July 18, 2013
First Posted: July 23, 2013
Last Update Posted: April 7, 2016
Last Verified: April 2016

Keywords provided by Ester Forastiere, Regina Elena Cancer Institute:
Balanced anesthesia
Inhalation anesthesia
Reperfusion injury
Microsurgical Free flap

Additional relevant MeSH terms:
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General