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Trial record 3 of 11 for:    Open Studies | "Surgery, Plastic"

Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Regina Elena Cancer Institute
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute Identifier:
First received: October 24, 2013
Last updated: November 5, 2014
Last verified: November 2014

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: January 2013
Estimated 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
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01972230

Contact: federica falcioni 00390652665353

Regina Elena Cancer Institute Recruiting
Rome, RM, Italy, 00144
Contact: Forastiere Ester    00390652662994   
Sub-Investigator: Claudia Claroni, MD         
Sponsors and Collaborators
Regina Elena Cancer Institute
  More Information

No publications provided

Responsible Party: Ester Forastiere, director, Regina Elena Cancer Institute Identifier: NCT01972230     History of Changes
Other Study ID Numbers: 17713, Claudia
Study First Received: October 24, 2013
Last Updated: November 5, 2014
Health Authority: Italy: Ethics Committee processed this record on March 03, 2015