Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01905501
Enrollment
132
Registered
2013-07-23
Start date
2013-02-28
Completion date
2015-02-28
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microsurgical Free Flaps

Keywords

Balanced anesthesia, Inhalation anesthesia, Reperfusion injury, Microsurgical Free flap

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.

Interventions

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

DRUGTotal intravenous anesthesia

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

Sponsors

Regina Elena Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
continuous tissue oximetry (NIRS)20 hours

Secondary

MeasureTime frame
Biochemical MarkersPreoperative and 24 hours post operative
Lactate Clearance24 hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026