The Effect of Volatile Anesthetics Sevoflurane and Desflu... | NCT01267786

Studies
The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery

NCT01267786

Sponsor

Aretaieio Hospital

Status

Unknown status

Last Update Posted

Dec 29, 2010Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Apoptosis
Liver Surgery

Interventions

Liver surgery

Countries

Greece

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

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Not provided

First Submitted Date

Dec 28, 2010

First Submission Date that Met QC Criteria

Dec 28, 2010

First Posted Date

Dec 29, 2010Estimated

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

Dec 28, 2010

Last Update Posted Date

Dec 29, 2010Estimated

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

The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic function after ischemic/reperfusion injury and the sequence influence on renal and cardiovascular systems.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Active Comparator	1MAC intraoperatively	Procedure: Liver surgery
desflurane	Active Comparator	1 MAC intraoperatively	Procedure: Liver surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver surgery	Procedure	hepatectomy	Sevoflurane desflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxidotic stress after hepatectomy.	Perioperative liver and renal biopsies and follow up with liver renal function tests plus intraoperative and postoperative cardiovascular monitoring	5 d postop.

Secondary Outcomes

Measure	Description	Time Frame
Liver and renal dysfunction	liver and renal impairment due to ischemic injury	5 d

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing liver surgery

Exclusion Criteria:

ASA IV, Cardiovascular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georgios P Fragulidis, MD	Contact	+30 6072910955		gfragulidis@aretaieio.uoa.gr
Aikaterini D Melemeni, MD, DESA	Contact	+30 6946194817		amelemeni@med.uoa.gr

Overall Officials

Name	Affiliation	Role
Georgios P Fragulidis, MD	Areataieio Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aretaieio Hospital	Recruiting	Athens	Attica	115 28	Greece