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General Anesthesia vs. Local Anesthesia in Stereotaxy (GALAXY)

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ClinicalTrials.gov Identifier: NCT01515852
Recruitment Status : Unknown
Verified February 2013 by Lutz Weise, Johann Wolfgang Goethe University Hospitals.
Recruitment status was:  Recruiting
First Posted : January 24, 2012
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Lutz Weise, Johann Wolfgang Goethe University Hospitals

Study Description
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Brief Summary:
Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy

Condition or disease Intervention/treatment Phase
Brain Lesion, Stereotactic Biopsy Procedure: general anesthesia in stereotactic biopsy Procedure: local anesthesia in stereotactic biopsy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: General Anesthesia vs. Local Anesthesia in Stereotaxy
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Biopsy
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. PTSS-10 [ Time Frame: Three days after operation ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned stereotactic biopsy
  • age > 18 years

Exclusion Criteria:

  • pregnancy
  • anxiety disorder
  • impaired consciousness
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Lutz Weise, Johann Wolfgang Goethe University Hospitals:
stress level
stereotactic biopsy
brain lesion
general anesthesia
local anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs