Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial
Not Applicable
Completed
- Conditions
- Microsurgical Free Flaps
- Interventions
- Drug: Balanced anesthesiaDrug: Total intravenous anesthesia
- Registration Number
- NCT01905501
- Lead Sponsor
- Regina Elena Cancer Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Balanced anesthesia Balanced anesthesia - Total intravenous anesthesia Total intravenous anesthesia Total intravenous anaesthesia
- Primary Outcome Measures
Name Time Method continuous tissue oximetry (NIRS) 20 hours
- Secondary Outcome Measures
Name Time Method Lactate Clearance 24 hours Biochemical Markers Preoperative and 24 hours post operative
Trial Locations
- Locations (1)
Regina Elena CI
🇮🇹Rome, Italy