Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Regina Elena Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT01972230
First received: October 24, 2013
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • 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 ClinicalTrials.gov identifier: NCT01972230

Contacts
Contact: federica falcioni 00390652665353 falciof@ifo.it

Locations
Italy
Regina Elena Cancer Institute Recruiting
Rome, RM, Italy, 00144
Contact: Forastiere Ester    00390652662994    forastiere@ifo.it   
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
ClinicalTrials.gov Identifier: NCT01972230     History of Changes
Other Study ID Numbers: 17713, Claudia
Study First Received: October 24, 2013
Last Updated: November 4, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Remifentanil
Sevoflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on September 18, 2014