COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01972230
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : April 7, 2016
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Microvascular Breast Flap in Plastic Surgery Drug: Sevoflurane Drug: Diprivan + Remifentanil TCI Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01972230

Layout table for location information
Regina Elena Cancer Institute
Rome, RM, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
Layout table for additonal information
Responsible Party: Ester Forastiere, director, Regina Elena Cancer Institute Identifier: NCT01972230    
Other Study ID Numbers: 17713
Claudia ( Registry Identifier: Claudia )
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Hypnotics and Sedatives
Anesthetics, Intravenous