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Completed

NCT Number: NCT01972230

Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

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.

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Key information

Conditions

Microvascular Breast Flap in Plastic Surgery

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regina Elena Cancer Institute

Rome, RM, 00144, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sevoflurane

Drug

Diprivan + Remifentanil TCI

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
First posted
Oct 30, 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.