Depth of Anesthesia Monitors, Movement Disorders
Conditions
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 30 |
Baseline characteristics
| Characteristic | BIS 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 type | EG000 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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T3 Loss of eyelash reflex | 59 units on a scale | Standard Deviation 5 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T8 Start of skin closure | 40 units on a scale | Standard Deviation 6 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T5 Knife to skin | 44 units on a scale | Standard Deviation 2 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T9 End of skin closure | 42 units on a scale | Standard Deviation 8 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T2 Loss of response to speech | 65 units on a scale | Standard Deviation 4 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T10 Anaesthetic agent turned off | 66 units on a scale | Standard Deviation 7 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T6 Maintenance (prior to tunneling) | 40 units on a scale | Standard Deviation 4 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T11 Obeying commands | 87 units on a scale | Standard Deviation 3 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T4 Intubation | 44 units on a scale | Standard Deviation 4 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T12 Extubation | 92 units on a scale | Standard Deviation 3 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T7 Tunneling in the neck | 36 units on a scale | Standard Deviation 6 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T13 Post-extubation | 93 units on a scale | Standard Deviation 3 |
| Bispectral Index BIS | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T1 Awake (preinduction) | 96 units on a scale | Standard Deviation 1 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T13 Post-extubation | 96 units on a scale | Standard Deviation 2 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T1 Awake (preinduction) | 96 units on a scale | Standard Deviation 3 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T2 Loss of response to speech | 77 units on a scale | Standard Deviation 9 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T3 Loss of eyelash reflex | 63 units on a scale | Standard Deviation 6 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T4 Intubation | 53 units on a scale | Standard Deviation 5 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T5 Knife to skin | 44 units on a scale | Standard Deviation 5 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T6 Maintenance (prior to tunneling) | 33 units on a scale | Standard Deviation 4 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T7 Tunneling in the neck | 32 units on a scale | Standard Deviation 5 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T8 Start of skin closure | 37 units on a scale | Standard Deviation 6 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T9 End of skin closure | 49 units on a scale | Standard Deviation 9 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T10 Anaesthetic agent turned off | 59 units on a scale | Standard Deviation 6 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T11 Obeying commands | 89 units on a scale | Standard Deviation 6 |
| Response Entropy Index | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices | T12 Extubation | 93 units on a scale | Standard Deviation 4 |