General Anesthesia vs. Local Anesthesia in Stereotaxy (GALAXY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014