Brain Lesion, Stereotactic BiopsyGALAXYNCT01515852
General Anesthesia vs. Local Anesthesia in Stereotaxy
A study testing general anesthesia in stereotactic biopsy and local anesthesia in stereotactic biopsy in people with Brain Lesion, Stereotactic Biopsy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Lesion, Stereotactic Biopsy
- What is being tested?
- general anesthesia in stereotactic biopsy and local anesthesia in stereotactic biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned stereotactic biopsy
- age > 18 years
Who cannot join
- pregnancy
- anxiety disorder
- impaired consciousness
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Johann Wolfgang Goethe University
Frankfurt am Main, 60528
Lutz Weise, M. D., (0049) 69 6301 ext. 5939, lutz.weise@med.uni-frankfurt.de
Lutz Weise, M. D.
About this study
Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy
Read the 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.
- Conditions
- Brain Lesion, Stereotactic Biopsy
- Being tested
- general anesthesia in stereotactic biopsy, local anesthesia in stereotactic biopsy
- Keywords
- stress level, stereotactic biopsy, brain lesion, general anesthesia, local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia in stereotactic biopsyProcedure or surgery
stereotactic biopsy
local anesthesia in stereotactic biopsyProcedure or surgery
stereotactic biopsy
| Study group | Role | What they receive |
|---|---|---|
| Stress level after general anesthesia | Other | Not described Receives: Procedure: general anesthesia in stereotactic biopsy |
| Stress level after local anesthesia | Other | Not described Receives: Procedure: local anesthesia in stereotactic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSS-10
Measured: Three days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Lesion, Stereotactic BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lutz Weise, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515852
- Sponsor's protocol ID
- JohannWGUH_GALAXY
- Acronym
- GALAXY
- Status last verified
- Feb 2013
- First submitted
- 23 Jan 2012
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia vs. Local Anesthesia in Stereotaxy
- ClinicalTrials.gov ID
- NCT01515852
- Acronym / sponsor ID
- GALAXY / JohannWGUH_GALAXY
- Conditions
- Brain Lesion, Stereotactic Biopsy
- Keywords
- stress level, stereotactic biopsy, brain lesion, general anesthesia, local anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress level after general anesthesia | Other | Procedure: general anesthesia in stereotactic biopsy |
| Stress level after local anesthesia | Other | Procedure: local anesthesia in stereotactic biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned stereotactic biopsy
- age > 18 years
Key exclusion criteria (3 listed)
- pregnancy
- anxiety disorder
- impaired consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesia in stereotactic biopsystereotactic biopsy | Procedure or surgery | Stress level after general anesthesia |
| local anesthesia in stereotactic biopsystereotactic biopsy | Procedure or surgery | Stress level after local anesthesia |
Primary outcome
PTSS-10
Time frame: Three days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia in stereotactic biopsy and local anesthesia in stereotactic biopsy in people with Brain Lesion, Stereotactic Biopsy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lutz Weise, M. D. ((0049) 69 6301 ext. 5939, lutz.weise@med.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSS-10 (time frame: Three days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.