NCT01905501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

July 18, 2013

Last Update Submit

April 6, 2016

Conditions

Microsurgical Free Flaps

Keywords

Balanced anesthesiaInhalation anesthesiaReperfusion injuryMicrosurgical Free flap

Outcome Measures

Primary Outcomes (1)

  • continuous tissue oximetry (NIRS)

    20 hours

Secondary Outcomes (2)

  • Biochemical Markers

    Preoperative and 24 hours post operative

  • Lactate Clearance

    24 hours

Study Arms (2)

Total intravenous anesthesia

ACTIVE COMPARATOR

Total intravenous anaesthesia

Drug: Total intravenous anesthesia

Balanced anesthesia

EXPERIMENTAL
Drug: Balanced anesthesia

Interventions

Balanced anesthesiaDRUG

Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml

Also known as: Inhalation anesthesia
Balanced anesthesia
Total intravenous anesthesiaDRUG

Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion

Also known as: TIVA-TCI
Total intravenous anesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II

You may not qualify if:

  • Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Elena CI

Rome, Italy, 00144, Italy

Location

Related Publications (1)

  • Claroni C, Torregiani G, Covotta M, Sofra M, Scotto Di Uccio A, Marcelli ME, Naccarato A, Forastiere E. Protective effect of sevoflurane preconditioning on ischemia-reperfusion injury in patients undergoing reconstructive plastic surgery with microsurgical flap, a randomized controlled trial. BMC Anesthesiol. 2016 Aug 22;16(1):66. doi: 10.1186/s12871-016-0230-1.

    PMID: 27549313DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Balanced AnesthesiaAnesthesia, Inhalation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, GeneralAnesthesiaAnesthesia and Analgesia

Study Officials

  • Ester Forastiere, M.D.

    Regina Elena CI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Chief of Critical Area Department

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 23, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

IT(1)