Vegetative Monitoring During Brainstem-associated Surgery

Completed

• Conditions: Brainstem Neoplasm; Brain Tumor, Recurrent; Vestibular Schwannoma; Brainstem Glioma
• Interventions: Procedure: Intraoperative Monitoring during resection of brain tumor

• Registration Number: NCT03666507
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-28
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Primary Completion: 2020-08-28
• Study Completion: 2021-03-28
• Status Verified: 2021-04
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• age 0-99
• brain tumor

Exclusion Criteria

• no consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumors without brain stem assocation	Intraoperative Monitoring during resection of brain tumor	Tumors without brain stem assocation
Brain stem associated tumors	Intraoperative Monitoring during resection of brain tumor	Brain stem associated tumors

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV)	intraoperatively	Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurosurgery; 🇩🇪 Tübingen, Germany