Skip to main content
Clinical Trials/NCT01972230
NCT01972230
Completed
Not Applicable

Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

Regina Elena Cancer Institute1 site in 1 country128 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Sevoflurane
Conditions
Microvascular Breast Flap in Plastic Surgery
Sponsor
Regina Elena Cancer Institute
Enrollment
128
Locations
1
Primary Endpoint
tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study aimed to evaluate the possible protective effect of anesthetic technique balanced (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion injury in microvascular flap in plastic surgery. The investigators will evaluate the viability of the flap using tissue oximetry monitoring and the level of biochemical markers in a circle at the end of the intervention.

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

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ester Forastiere

director

Regina Elena Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • age \> 18 yr
  • ASA (American Society of Anesthesiology) I-II

Exclusion Criteria

  • Known unusual reaction to anesthetic drugs
  • Evaluation of anesthesia increased risk for malignant hyperthermia.
  • History of vascular disease.
  • History of bleeding diathesis.

Arms & Interventions

Bilanced group

Sevofluorane adjusted to obtain an Et-Sevo of 1.8-2%, for all the time of the surgical procedure. Remifentanyl TCI adjusted according to protocol to maintain the range of 1-3 ng / ml.

Intervention: Sevoflurane

TCI group

Propofol 3-4 mg / ml and remifentanyl 1-3 ng / ml according to protocol TCI

Intervention: Diprivan + Remifentanil TCI

Outcomes

Primary Outcomes

tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously.

Time Frame: 24 hours from the end of intervention

Study Sites (1)

Loading locations...

Similar Trials