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

N/ACompletedNCT01905501

Regina Elena Cancer Institute132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Microsurgical Free Flaps

Interventions

Balanced anesthesiaDRUG

Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml

Total intravenous anesthesiaDRUG

Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Regina Elena CI

Rome, Italy, Italy

Outcomes

Primary Outcomes

continuous tissue oximetry (NIRS)

Time frame: 20 hours

Secondary Outcomes

Biochemical Markers

Time frame: Preoperative and 24 hours post operative

Lactate Clearance

Time frame: 24 hours

Data from ClinicalTrials.gov

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