Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT01972230
First received: October 24, 2013
Last updated: April 6, 2016
Last verified: April 2016
  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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01972230

Locations
Italy
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
ClinicalTrials.gov Identifier: NCT01972230     History of Changes
Other Study ID Numbers: 17713  Claudia 
Study First Received: October 24, 2013
Last Updated: April 6, 2016
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 24, 2016