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CompletedNCT03666507Updated Nov 4, 2022

Vegetative Monitoring During Brainstem-associated Surgery

An observational study in Brain Tumor, Recurrent, Vestibular Schwannoma and Brainstem Neoplasm, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
103
Sex
All
01

Study summary

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

02

Conditions studied

  • Brain Tumor, Recurrent
  • Vestibular Schwannoma
  • Brainstem Neoplasm
  • Brainstem Glioma
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 103 is close to the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Brain tumor patients

Inclusion criteria

  • age 0-99
  • brain tumor

Exclusion criteria

Exclusion Criteria:

  • no consent
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No

Groups and cohorts

  • Brain stem associated tumors

    Brain stem associated tumors

    Procedure: 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

Interventions

  • ProcedureIntraoperative Monitoring during resection of brain tumor

    Intraoperative Monitoring during resection of brain tumor

06

What researchers measure

Primary outcomes

  1. Heart rate variability (HRV)

    Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery)

    Time frame: intraoperatively

Secondary outcomes

  1. Rate of cardiovascular complications

    Comparison of no. of cardiovascular complications (cardiac arrest, sudden tachy/bradyarryhthmia, hyper/hypotension, trigeminocardiac reflex) in the 2 groups

    Time frame: intraoperatively

07

Study locations

1 site
  • Department of Neurosurgery
    Tübingen, 72076, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03666507
Lead sponsor
University Hospital Tuebingen
Responsible party
Sponsor
First posted
Sep 11, 2018
Start date
Aug 28, 2018
Primary completion
Aug 28, 2020
Completion
Mar 28, 2021
Last update
Nov 4, 2022

Study contacts

Martin U Schuhmann, Prof
principal investigator · University Hospital Tuebingen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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