Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

Regina Elena Cancer Institute

Status: Completed

Conditions: Microvascular Breast Flap in Plastic Surgery

Treatments: Drug: Sevoflurane; Drug: Diprivan + Remifentanil TCI

Study type: Interventional

Funder types: Other

Identifiers

NCT01972230

17713

Claudia (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Bilanced group

Experimental group

Description:

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.

Treatment:

Drug: Sevoflurane

TCI group

Active Comparator group

Description:

Propofol 3-4 mg / ml and remifentanyl 1-3 ng / ml according to protocol TCI

Treatment:

Drug: Diprivan + Remifentanil TCI