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Clinical Trials/NCT02386995
NCT02386995
Completed
Not Applicable

Comparison of Bispectral Index and Entropy Monitoring in Patients Undergoing Internalization of Deep Brain Simulation

University Health Network, Toronto1 site in 1 country30 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Movement Disorders
Sponsor
University Health Network, Toronto
Enrollment
30
Locations
1
Primary Endpoint
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological conditions such as Parkinson's disease by comparing these monitoring with standard clinical monitoring like heart rate, blood pressure and respiratory rate.

Detailed Description

Deep brain simulation (DBS) is an increasingly popular treatment for movement and psychiatric disorders such as Parkinson's disease and dystonia. These patients are quite sensitive to anesthetics and use of depth of anesthesia monitors are often needed to titrate the anesthetics. The calibration of BIS and entropy monitors has been done only on subjects with no neurological diseases. The investigators plan to record BIS and entropy readings during general anesthesia (GA) for the internalization of DBS electrodes. This would be useful as there are very few studies in this subset of patients with regards to DOA monitoring. Ashraf argued that the EEG may be altered under these circumstances and hence produce invalid BIS readings. Pemberton et al. studied patients undergoing tumour surgery using a sleep- awake-sleep anaesthesia technique. They found a poor correlation between BIS values and the observer's assessment of anesthesia level, suggesting that BIS is not a reliable tool for patients with brain abnormalities. The purpose of this study was to investigate whether BIS and entropy are helpful in titrating DOA in patients undergoing neurosurgical procedures or suffering from neurological diseases as they were frequently excluded from validation studies of the BIS monitoring device.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
March 2014
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lashmi Venkatraghavan

Dr.

University Health Network, Toronto

Eligibility Criteria

Inclusion Criteria

  • Adult patients older than 18 years of age scheduled for elective internalisation of DBS electrodes under general anesthesia.

Exclusion Criteria

  • lack of informed consent
  • language barrier
  • those that are transferred to an intensive care unit postoperatively.

Outcomes

Primary Outcomes

Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices

Time Frame: One day

The trends of Bispectral (BIS) and Response entropy (RE) at different study time points. Bispectral (BIS) and Response entropy (RE) values range from 0 (absence of brain activity) to 100 (fully awake state). Values below 40 indicate deep anesthesia, values from 40 to 60 optimal and above 60 but below 90 inadequate anesthesia.

Study Sites (1)

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