We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

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: NCT01905501
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : April 7, 2016
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Microsurgical Free Flaps Drug: Balanced anesthesia Drug: Total intravenous anesthesia Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
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.
Study Start Date : February 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : February 2015

Arm Intervention/treatment
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

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

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

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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

Layout table for location information
Regina Elena CI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
Layout table for investigator information
Principal Investigator: Ester Forastiere, M.D. Regina Elena CI
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ester Forastiere, M.D., Chief of Critical Area Department, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT01905501    
Other Study ID Numbers: Versione 02.01.2013
First Posted: July 23, 2013    Key Record Dates
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:
Layout table for MeSH terms
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Central Nervous System Depressants
Physiological Effects of Drugs