Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

April 6, 2016 updated by: Ester Forastiere, Regina Elena Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00144
        • Regina Elena Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.
  • Tabagism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Sevoflurane
Active Comparator: TCI group
Propofol 3-4 mg / ml and remifentanyl 1-3 ng / ml according to protocol TCI
Drug: Diprivan + Remifentanil TCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 hours from the end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

October 29, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17713
  • Claudia (Registry Identifier: Claudia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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