General Anesthesia vs. Local Anesthesia in Stereotaxy | NCT01515852

Studies
General Anesthesia vs. Local Anesthesia in Stereotaxy

NCT01515852

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Feb 21, 2013Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Brain Lesion, Stereotactic Biopsy

Interventions

general anesthesia in stereotactic biopsy
local anesthesia in stereotactic biopsy

Countries

Germany

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

Feb 2013

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

Jan 2012

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Jan 23, 2012

First Submission Date that Met QC Criteria

Jan 23, 2012

First Posted Date

Jan 24, 2012Estimated

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

Feb 20, 2013

Last Update Posted Date

Feb 21, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lutz Weise, Lutz Weise, M. D. Goethe University, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

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

Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy

Detailed Description

Stereotactic biopsy is routinely performed under local or general anesthesia. The advantage of local anesthesia might be reduction in cardiac and pulmonal complications, reduction of surgical time, and reduction of hospital stay. On the other hand it has been postulated that intraoperative seizures are avoided by general anesthesia and that brain tumor surgery is perceived in the public as psychological and physical stress.Therefor we postulate that patients undergoing stereotactic biopsies in local anesthesia show a higher stress level than patients operated under general anesthesia.

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress level after general anesthesia	Other		Procedure: general anesthesia in stereotactic biopsy
Stress level after local anesthesia	Other		Procedure: local anesthesia in stereotactic biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
general anesthesia in stereotactic biopsy	Procedure	stereotactic biopsy	Stress level after general anesthesia

Measure	Description	Time Frame
PTSS-10		Three days after operation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

planned stereotactic biopsy
age > 18 years

Exclusion Criteria:

pregnancy
anxiety disorder
impaired consciousness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lutz Weise, M. D.	Contact	(0049) 69 6301	5939	lutz.weise@med.uni-frankfurt.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery, Johann Wolfgang Goethe University	Recruiting	Frankfurt am Main		60528	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D000768	Anesthesia, General
D000772	Anesthesia, Local

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia
D000765	Anesthesia, Conduction

Browse Leaves

Not provided

Browse Branches

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