BIS and Entropy in Deep Brain Simulation

Completed

• Conditions: Depth of Anesthesia Monitors; Movement Disorders
• Interventions: Device: BIS monitor; Device: Entropy monitor

• Registration Number: NCT02386995
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-11-28
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-12
• Results First Submitted: 2020-05-11
• Results First Submitted QC: 2020-12-01
• Results First Posted: 2020-12-24
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIS and Entropy monitoring	BIS monitor	Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.
BIS and Entropy monitoring	Entropy monitor	Depth of anesthesia monitoring (BIS and entropy) are compared with standard clinical monitoring in patients with deep brain stimulators inserted at internalization whilst they are having a general anesthesia.

Primary Outcome Measures

Name	Time	Method
Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices	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.

Trial Locations

Locations (1)

University Heath Network, Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada