Sevoflurane Protective Effect on Ischemia Reperfusion Inj... | NCT01972230

Studies
Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

NCT01972230

Sponsor

Regina Elena Cancer Institute

Status

Completed

Last Update Posted

Apr 7, 2016Estimated

Enrollment

128Actual

Phase

Not Applicable

Conditions

Microvascular Breast Flap in Plastic Surgery

Interventions

Sevoflurane
Diprivan + Remifentanil TCI

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Claudia	Registry Identifier	Claudia

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2015Actual

Completion Date

Not provided

First Submitted Date

Oct 24, 2013

First Submission Date that Met QC Criteria

Oct 29, 2013

First Posted Date

Oct 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2016

Last Update Posted Date

Apr 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug		Bilanced group
Diprivan + Remifentanil TCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tissutal oximetry average value of the flap measured with INVOS (In Vivo Optical Spectroscopy) system continuously.		24 hours from the end of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regina Elena Cancer Institute		Rome	RM	00144	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D015742	Propofol

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

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