Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Regina Elena Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT01905501
First received: July 18, 2013
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.


Condition Intervention
Microsurgical Free Flaps
Drug: Balanced anesthesia
Drug: Total intravenous anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Regina Elena Cancer Institute:

Primary Outcome Measures:
  • continuous tissue oximetry (NIRS) [ Time Frame: 20 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biochemical Markers [ Time Frame: Preoperative and 24 hours post operative ] [ Designated as safety issue: Yes ]
  • Lactate Clearance [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 132
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total intravenous anesthesia
Total intravenous anaesthesia
Drug: Total intravenous anesthesia
Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion
Other Name: TIVA-TCI
Experimental: Balanced anesthesia Drug: Balanced anesthesia
Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml
Other Name: Inhalation anesthesia

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II

Exclusion Criteria:

Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease

  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: NCT01905501

Contacts
Contact: Ester Forastiere forastiere@ifo.it

Locations
Italy
Regina Elena CI Recruiting
Rome, Italy, 00144
Contact: Ester Forastiere, M.D.       forastiere@ifo.it   
Principal Investigator: Ester Forastiere, M.D.         
Sponsors and Collaborators
Regina Elena Cancer Institute
Investigators
Principal Investigator: Ester Forastiere, M.D. Regina Elena CI
  More Information

No publications provided

Responsible Party: Ester Forastiere, M.D., Chief of Critical Area Department, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT01905501     History of Changes
Other Study ID Numbers: Versione 02.01.2013
Study First Received: July 18, 2013
Last Updated: July 22, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Regina Elena Cancer Institute:
Balanced anesthesia
Inhalation anesthesia
Reperfusion injury
Microsurgical Free flap

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Inhalation
Anesthetics, General
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on October 01, 2014