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BIS and Entropy in Deep Brain Simulation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02386995
Enrollment
30
Registered
2015-03-12
Start date
2013-07-31
Completion date
2014-03-31
Last updated
2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depth of Anesthesia Monitors, Movement Disorders

Keywords

depth of anesthesia monitors, deep brain stimulation

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.

Interventions

Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.

DEVICEEntropy monitor

Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation Between Bispectral (BIS) and Response Entropy (RE) IndicesOne dayThe 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.

Countries

Canada

Participant flow

Participants by arm

ArmCount
BIS and Entropy Monitoring
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 monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared. Entropy monitor: Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia
30
Total30

Baseline characteristics

CharacteristicBIS and Entropy Monitoring
Age, Customized
Age
58.4 years
STANDARD_DEVIATION 11
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
18 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
0 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

Primary

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

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.

Time frame: One day

Population: Correlation analysis between BIS and RE from pre-induction time (T1) until the surgical closure time (T9) 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.

ArmMeasureGroupValue (MEAN)Dispersion
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT3 Loss of eyelash reflex59 units on a scaleStandard Deviation 5
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT8 Start of skin closure40 units on a scaleStandard Deviation 6
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT5 Knife to skin44 units on a scaleStandard Deviation 2
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT9 End of skin closure42 units on a scaleStandard Deviation 8
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT2 Loss of response to speech65 units on a scaleStandard Deviation 4
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT10 Anaesthetic agent turned off66 units on a scaleStandard Deviation 7
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT6 Maintenance (prior to tunneling)40 units on a scaleStandard Deviation 4
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT11 Obeying commands87 units on a scaleStandard Deviation 3
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT4 Intubation44 units on a scaleStandard Deviation 4
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT12 Extubation92 units on a scaleStandard Deviation 3
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT7 Tunneling in the neck36 units on a scaleStandard Deviation 6
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT13 Post-extubation93 units on a scaleStandard Deviation 3
Bispectral Index BISCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT1 Awake (preinduction)96 units on a scaleStandard Deviation 1
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT13 Post-extubation96 units on a scaleStandard Deviation 2
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT1 Awake (preinduction)96 units on a scaleStandard Deviation 3
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT2 Loss of response to speech77 units on a scaleStandard Deviation 9
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT3 Loss of eyelash reflex63 units on a scaleStandard Deviation 6
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT4 Intubation53 units on a scaleStandard Deviation 5
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT5 Knife to skin44 units on a scaleStandard Deviation 5
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT6 Maintenance (prior to tunneling)33 units on a scaleStandard Deviation 4
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT7 Tunneling in the neck32 units on a scaleStandard Deviation 5
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT8 Start of skin closure37 units on a scaleStandard Deviation 6
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT9 End of skin closure49 units on a scaleStandard Deviation 9
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT10 Anaesthetic agent turned off59 units on a scaleStandard Deviation 6
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT11 Obeying commands89 units on a scaleStandard Deviation 6
Response Entropy IndexCorrelation Between Bispectral (BIS) and Response Entropy (RE) IndicesT12 Extubation93 units on a scaleStandard Deviation 4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026