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Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

This study has been completed.
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute Identifier:
First received: October 24, 2013
Last updated: April 6, 2016
Last verified: April 2016
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.

Condition Intervention
Microvascular Breast Flap in Plastic Surgery Drug: Sevoflurane Drug: Diprivan + Remifentanil TCI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Ester Forastiere, Regina Elena Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Enrollment: 128
Study Start Date: January 2013
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01972230

Regina Elena Cancer Institute
Rome, RM, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
  More Information

Responsible Party: Ester Forastiere, director, Regina Elena Cancer Institute Identifier: NCT01972230     History of Changes
Other Study ID Numbers: 17713
Claudia ( Registry Identifier: Claudia )
Study First Received: October 24, 2013
Last Updated: April 6, 2016

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation processed this record on June 23, 2017