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

Primary Purpose

Microsurgical Free Flaps

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Balanced anesthesia
Total intravenous anesthesia
Sponsored by
Regina Elena Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microsurgical Free Flaps focused on measuring Balanced anesthesia, Inhalation anesthesia, Reperfusion injury, Microsurgical Free flap

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Regina Elena CI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Total intravenous anesthesia

Balanced anesthesia

Arm Description

Total intravenous anaesthesia

Outcomes

Primary Outcome Measures

continuous tissue oximetry (NIRS)

Secondary Outcome Measures

Biochemical Markers
Lactate Clearance

Full Information

First Posted
July 18, 2013
Last Updated
April 6, 2016
Sponsor
Regina Elena Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01905501
Brief Title
Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial
Official Title
Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microsurgical Free Flaps
Keywords
Balanced anesthesia, Inhalation anesthesia, Reperfusion injury, Microsurgical Free flap

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total intravenous anesthesia
Arm Type
Active Comparator
Arm Description
Total intravenous anaesthesia
Arm Title
Balanced anesthesia
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Balanced anesthesia
Other Intervention Name(s)
Inhalation anesthesia
Intervention Description
Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml
Intervention Type
Drug
Intervention Name(s)
Total intravenous anesthesia
Other Intervention Name(s)
TIVA-TCI
Intervention Description
Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion
Primary Outcome Measure Information:
Title
continuous tissue oximetry (NIRS)
Time Frame
20 hours
Secondary Outcome Measure Information:
Title
Biochemical Markers
Time Frame
Preoperative and 24 hours post operative
Title
Lactate Clearance
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Forastiere, M.D.
Organizational Affiliation
Regina Elena CI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regina Elena CI
City
Rome
ZIP/Postal Code
00144
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27549313
Citation
Claroni C, Torregiani G, Covotta M, Sofra M, Scotto Di Uccio A, Marcelli ME, Naccarato A, Forastiere E. Protective effect of sevoflurane preconditioning on ischemia-reperfusion injury in patients undergoing reconstructive plastic surgery with microsurgical flap, a randomized controlled trial. BMC Anesthesiol. 2016 Aug 22;16(1):66. doi: 10.1186/s12871-016-0230-1.
Results Reference
derived

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

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