Vegetative Monitoring During Brainstem-associated Surgery

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03666507
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor, Recurrent; Vestibular Schwannoma; Brainstem Neoplasm; Brainstem Glioma	Procedure: Intraoperative Monitoring during resection of brain tumor

Study Design

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

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Heart rate variability (HRV) [intraoperatively]

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

Secondary Outcome Measures

1. Rate of cardiovascular complications [intraoperatively]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 0-99

• brain tumor

Exclusion Criteria:

• no consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery	Tübingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Martin U Schuhmann, Prof, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03666507
• Other Study ID Numbers: ANSTue
• First Posted: Sep 11, 2018
• Last Update Posted: Sep 11, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Neoplasms; Neurilemmoma; Neuroma, Acoustic; Brain Stem Neoplasms

Study Results

No Results Posted as of Sep 11, 2018