General Anesthesia vs. Local Anesthesia in Stereotaxy (GALAXY)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2013 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Lutz Weise, Johann Wolfgang Goethe University Hospitals

ClinicalTrials.gov Identifier:

NCT01515852

First received: January 23, 2012

Last updated: February 20, 2013

Last verified: February 2013

History of Changes

Purpose

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

Condition	Intervention
Brain Lesion, Stereotactic Biopsy	Procedure: general anesthesia in stereotactic biopsy Procedure: local anesthesia in stereotactic biopsy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	General Anesthesia vs. Local Anesthesia in Stereotaxy

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

PTSS-10 [ Time Frame: Three days after operation ] [ Designated as safety issue: No ]


Estimated Enrollment:	80
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stress level after general anesthesia	Procedure: general anesthesia in stereotactic biopsy stereotactic biopsy
Stress level after local anesthesia	Procedure: local anesthesia in stereotactic biopsy 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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

planned stereotactic biopsy
age > 18 years

Exclusion Criteria:

pregnancy
anxiety disorder
impaired consciousness

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515852

Contacts


Contact: Lutz Weise, M. D.	(0049) 69 6301 ext 5939	lutz.weise@med.uni-frankfurt.de

Locations


Germany
Department of Neurosurgery, Johann Wolfgang Goethe University	Recruiting
Frankfurt am Main, Germany, 60528
Contact: Lutz Weise, M. D. (0049) 69 6301 ext 5939 lutz.weise@med.uni-frankfurt.de
Principal Investigator: Lutz Weise, M. D.

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

More Information

No publications provided


Responsible Party:	Lutz Weise, Lutz Weise, M. D. Goethe University, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT01515852 History of Changes
Other Study ID Numbers:	JohannWGUH_GALAXY
Study First Received:	January 23, 2012
Last Updated:	February 20, 2013
Health Authority:	Regierungspräsidium Darmstadt: Germany

Keywords provided by Johann Wolfgang Goethe University Hospitals:


stress level stereotactic biopsy brain lesion general anesthesia local anesthesia

Additional relevant MeSH terms:


Anesthetics Central Nervous System Agents Central Nervous System Depressants	Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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