Preconditioning Volatile Anesthesia in Liver Surgery | NCT01021228

Studies
Preconditioning Volatile Anesthesia in Liver Surgery

NCT01021228

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Nov 26, 2009Estimated

Enrollment

257Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

Not provided

Countries

Switzerland

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

Nov 2009

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

Aug 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Nov 25, 2009

First Submission Date that Met QC Criteria

Nov 25, 2009

First Posted Date

Nov 26, 2009Estimated

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

Nov 25, 2009

Last Update Posted Date

Nov 26, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to compare the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Detailed Description

Comparing the impact and outcome of continuous volatile anesthesia to continuous intravenous anesthesia and to preconditioning volatile anesthesia in liver surgery.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

257Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group1		continuous volatile anesthesia (sevoflurane) during the liver resection
group2		continuous intravenous anesthesia (propofol) during the liver resection
group3		preconditioning volatile anesthesia (sevoflurane) 30 minutes before ischemia (inflow occlusion)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peak ALT and AST levels representing the ischemia-reperfusion injury		post-operative

Secondary Outcomes

Measure	Description	Time Frame
length of hospital stay, length of ICU stay, blood loss and morbidity (post-operative complications)		post-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years
benign and malign disease
any type of liver surgery
inflow occlusion during the liver surgery

Exclusion Criteria:

< 18 years
participation on other interventional and treatment randomized controlled trials,
trauma of the liver
liver cirrhosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients were included undergoing any type of liver resection with inflow occlusion for benign as well as malign diseases between January first, 2005 and December 31, 2007 in a single tertiary care center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ksenija Slankamenac, med. pract	Departement of Visceral and Transplantation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universtiy Hospital of Zurich, Department of Visceral and Transplantation Surgery		Zurich	Canton of Zurich	8091	Switzerland