General Anesthesia vs. Local Anesthesia in Stereotaxy (GALAXY)
This study is currently recruiting participants.
Verified February 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
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
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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 |
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
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 Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013