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Completed

NCT Number: NCT01905501

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

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.

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Key information

Conditions

Microsurgical Free Flaps Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regina Elena CI

Rome, Italy, 00144

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balanced anesthesia

Drug

Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml

Other names: Inhalation anesthesia

Total intravenous anesthesia

Drug

Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion

Other names: TIVA-TCI

Primary outcomes

  1. continuous tissue oximetry (NIRS)

    Time frame: 20 hours

Secondary outcomes

  1. Biochemical Markers

    Time frame: Preoperative and 24 hours post operative

  2. Lactate Clearance

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 23, 2013
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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