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NCT03666507 Clinical Trial

Vegetative Monitoring During Brainstem-associated Surgery

Vestibular Schwannoma Clinical Trial

Official title:
Vegetative Monitoring During Brainstem-associated Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03666507
Other study ID # ANSTue
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 28, 2018
Est. completion date March 28, 2021

Study information
Verified date April 2021
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 103
Est. completion date March 28, 2021
Est. primary completion date August 28, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - age 0-99 - brain tumor Exclusion Criteria: - no consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intraoperative Monitoring during resection of brain tumor
Intraoperative Monitoring during resection of brain tumor

Locations
Country Name City State
Germany Department of Neurosurgery Tübingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart rate variability (HRV) Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery) intraoperatively
Secondary Rate of cardiovascular complications Comparison of no. of cardiovascular complications (cardiac arrest, sudden tachy/bradyarryhthmia, hyper/hypotension, trigeminocardiac reflex) in the 2 groups intraoperatively
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