NCT01972230

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

October 24, 2013

Last Update Submit

April 6, 2016

Conditions

Microvascular Breast Flap in Plastic Surgery

Outcome Measures

Primary Outcomes (1)

  • tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously.

    24 hours from the end of intervention

Study Arms (2)

Bilanced group

EXPERIMENTAL

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.

Drug: Sevoflurane

TCI group

ACTIVE COMPARATOR

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

Drug: Diprivan + Remifentanil TCI

Interventions

SevofluraneDRUG
Bilanced group
Diprivan + Remifentanil TCIDRUG
TCI group

Eligibility Criteria

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

You may qualify if:

  • age \> 18 yr
  • ASA (American Society of Anesthesiology) I-II

You may not qualify if:

  • Known unusual reaction to anesthetic drugs
  • Evaluation of anesthesia increased risk for malignant hyperthermia.
  • History of vascular disease.
  • History of bleeding diathesis.
  • Tabagism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Elena Cancer Institute

Rome, RM, 00144, Italy

Location

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

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
director

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 30, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

IT(1)