- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01515852
General Anesthesia vs. Local Anesthesia in Stereotaxy (GALAXY)
February 20, 2013 updated by: Lutz Weise, Johann Wolfgang Goethe University Hospital
Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lutz Weise, M. D.
- Phone Number: 5939 (0049) 69 6301
- Email: lutz.weise@med.uni-frankfurt.de
Study Locations
-
-
-
Frankfurt am Main, Germany, 60528
- Recruiting
- Department of Neurosurgery, Johann Wolfgang Goethe University
-
Contact:
- Lutz Weise, M. D.
- Phone Number: 5939 (0049) 69 6301
- Email: lutz.weise@med.uni-frankfurt.de
-
Principal Investigator:
- Lutz Weise, M. D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- planned stereotactic biopsy
- age > 18 years
Exclusion Criteria:
- pregnancy
- anxiety disorder
- impaired consciousness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stress level after general anesthesia
|
stereotactic biopsy
|
Other: Stress level after local anesthesia
|
stereotactic biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PTSS-10
Time Frame: Three days after operation
|
Three days after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
January 1, 2014
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
January 23, 2012
First Submitted That Met QC Criteria
January 23, 2012
First Posted (Estimate)
January 24, 2012
Study Record Updates
Last Update Posted (Estimate)
February 21, 2013
Last Update Submitted That Met QC Criteria
February 20, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JohannWGUH_GALAXY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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