GALAXY: General Anesthesia vs. Local Anesthesia in Stereotaxy

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01515852
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Jan 1, 2012
• Anticipated Primary Completion Date: Jan 1, 2014
• Anticipated Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Stress level after general anesthesia	Procedure: general anesthesia in stereotactic biopsy; stereotactic biopsy
Other: Stress level after local anesthesia	Procedure: local anesthesia in stereotactic biopsy; stereotactic biopsy

Outcome Measures

Primary Outcome Measures

1. PTSS-10 [Three days after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• planned stereotactic biopsy

• age > 18 years

Exclusion Criteria:

• pregnancy

• anxiety disorder

• impaired consciousness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery, Johann Wolfgang Goethe University	Frankfurt am Main		Germany	60528

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lutz Weise, Lutz Weise, M. D. Goethe University, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT01515852
• Other Study ID Numbers: JohannWGUH_GALAXY
• First Posted: Jan 24, 2012
• Last Update Posted: Feb 21, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Lutz Weise, Lutz Weise, M. D. Goethe University, Johann Wolfgang Goethe University Hospital: stress level; stereotactic biopsy; brain lesion; general anesthesia; local anesthesia
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Feb 21, 2013