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

Regina Elena Cancer Institute

Status: Completed

Conditions: Microsurgical Free Flaps

Treatments: Drug: Total intravenous anesthesia; Drug: Balanced anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01905501

Versione 02.01.2013

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Total intravenous anesthesia

Active Comparator group

Description:

Total intravenous anaesthesia

Treatment:

Drug: Total intravenous anesthesia

Balanced anesthesia

Experimental group

Treatment:

Drug: Balanced anesthesia