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

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

Study Description
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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

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
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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


Locations
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Italy
Regina Elena CI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
Investigators
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Principal Investigator: Ester Forastiere, M.D. Regina Elena CI
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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:
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Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
 Postoperative Complications
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs