General Anesthesia vs. Local Anesthesia in Stereotaxy

Brain Lesion, Stereotactic Biopsy Clinical Trial

— GALAXY  

Official title:

General Anesthesia vs. Local Anesthesia in Stereotaxy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01515852
• Other study ID #: JohannWGUH_GALAXY
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2012
• Last updated: February 20, 2013
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2013
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Lutz Weise, M. D.
• Phone: (0049) 69 6301
• Email: lutz.weise[@]med.uni-frankfurt.de
• Is FDA regulated: No
• Health authority: Regierungspräsidium Darmstadt: Germany
• Study type: Interventional

Clinical Trial Summary

Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• planned stereotactic biopsy

• age > 18 years

Exclusion Criteria:

• pregnancy

• anxiety disorder

• impaired consciousness

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Lesion, Stereotactic Biopsy

Intervention

Procedure:
• general anesthesia in stereotactic biopsy
stereotactic biopsy
• local anesthesia in stereotactic biopsy
stereotactic biopsy

Locations

Country	Name	City	State
Germany	Department of Neurosurgery, Johann Wolfgang Goethe University	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSS-10		Three days after operation	No