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Clinical Trials/NCT01905501
NCT01905501
Completed
Not Applicable

Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.

Regina Elena Cancer Institute1 site in 1 country132 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Total intravenous anesthesia
Conditions
Microsurgical Free Flaps
Sponsor
Regina Elena Cancer Institute
Enrollment
132
Locations
1
Primary Endpoint
continuous tissue oximetry (NIRS)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ester Forastiere

M.D., Chief of Critical Area Department

Regina Elena Cancer Institute

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

Arms & Interventions

Total intravenous anesthesia

Total intravenous anaesthesia

Intervention: Total intravenous anesthesia

Balanced anesthesia

Intervention: Balanced anesthesia

Outcomes

Primary Outcomes

continuous tissue oximetry (NIRS)

Time Frame: 20 hours

Secondary Outcomes

  • Biochemical Markers(Preoperative and 24 hours post operative)
  • Lactate Clearance(24 hours)

Study Sites (1)

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