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

Microsurgical Free Flaps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905501
• Other study ID #: Versione 02.01.2013
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: April 6, 2016
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Microsurgical Free Flaps
• Reperfusion Injury

Intervention

Drug:
• Balanced anesthesia
Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml
• Total intravenous anesthesia
Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion

Locations

Country	Name	City	State
Italy	Regina Elena CI	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	continuous tissue oximetry (NIRS)		20 hours	Yes
Secondary	Biochemical Markers		Preoperative and 24 hours post operative	Yes
Secondary	Lactate Clearance		24 hours	Yes