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Vegetative Monitoring During Brainstem-associated Surgery

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ClinicalTrials.gov Identifier: NCT03666507
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.

Condition or disease Intervention/treatment
Brain Tumor, Recurrent Vestibular Schwannoma Brainstem Neoplasm Brainstem Glioma Procedure: Intraoperative Monitoring during resection of brain tumor

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vegetative Monitoring During Brainstem-associated Surgery
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : August 28, 2019
Estimated Study Completion Date : August 28, 2020


Group/Cohort Intervention/treatment
Brain stem associated tumors
Brain stem associated tumors
Procedure: Intraoperative Monitoring during resection of brain tumor
Intraoperative Monitoring during resection of brain tumor

Tumors without brain stem assocation
Tumors without brain stem assocation
Procedure: Intraoperative Monitoring during resection of brain tumor
Intraoperative Monitoring during resection of brain tumor




Primary Outcome Measures :
  1. Heart rate variability (HRV) [ Time Frame: intraoperatively ]
    Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery)


Secondary Outcome Measures :
  1. Rate of cardiovascular complications [ Time Frame: intraoperatively ]
    Comparison of no. of cardiovascular complications (cardiac arrest, sudden tachy/bradyarryhthmia, hyper/hypotension, trigeminocardiac reflex) in the 2 groups



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Brain tumor patients
Criteria

Inclusion Criteria:

  • age 0-99
  • brain tumor

Exclusion Criteria:

  • no consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666507


Contacts
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Contact: Julian Zipfel, MD +497071290 julian.zipfel@med.uni-tuebingen.de

Locations
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Germany
Department of Neurosurgery Recruiting
Tübingen, Germany, 72076
Contact: Julian Zipfel, MD    +497071290      
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Martin U Schuhmann, Prof University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03666507     History of Changes
Other Study ID Numbers: ANSTue
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Neurilemmoma
Neuroma, Acoustic
Brain Stem Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Infratentorial Neoplasms