BIS and Entropy in Deep Brain Simulation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: 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.
Device: 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
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Heath Network, Toronto Western Hospital | Toronto | Ontario | Canada | M5T 2S8 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Lashmi Venkatraghavan, University Health Network, Toronto Western Hospital
- Principal Investigator: Pirjo Manninen, University Heath Network, Toronto Western Hospital
- Principal Investigator: Audrey MY Tan, University Heath Network, Toronto Western Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13-6060-BE
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | BIS and Entropy Monitoring |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | BIS and Entropy Monitoring |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 30 |
| Age, Customized (years) [Mean (Standard Deviation) ] | |
| Age |
58.4
(11)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
40%
|
| Male |
18
60%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Bispectral Index BIS | Response Entropy Index |
|---|---|---|
| Arm/Group Description | The trends of Bispectral index (BIS) at different study time points (T) | The trends of Response Entropy index (RE) at different study time points (T) |
| Measure Participants | 30 | 30 |
| T1 Awake (preinduction) |
96
(1)
|
96
(3)
|
| T2 Loss of response to speech |
65
(4)
|
77
(9)
|
| T3 Loss of eyelash reflex |
59
(5)
|
63
(6)
|
| T4 Intubation |
44
(4)
|
53
(5)
|
| T5 Knife to skin |
44
(2)
|
44
(5)
|
| T6 Maintenance (prior to tunneling) |
40
(4)
|
33
(4)
|
| T7 Tunneling in the neck |
36
(6)
|
32
(5)
|
| T8 Start of skin closure |
40
(6)
|
37
(6)
|
| T9 End of skin closure |
42
(8)
|
49
(9)
|
| T10 Anaesthetic agent turned off |
66
(7)
|
59
(6)
|
| T11 Obeying commands |
87
(3)
|
89
(6)
|
| T12 Extubation |
92
(3)
|
93
(4)
|
| T13 Post-extubation |
93
(3)
|
96
(2)
|
Adverse Events
| Time Frame | one day | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | BIS and Entropy Monitoring | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| BIS and Entropy Monitoring | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Serious Adverse Events |
||
| BIS and Entropy Monitoring | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| BIS and Entropy Monitoring | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Emad Al Azazi |
|---|---|
| Organization | Toronto Western Hospital/UHN |
| Phone | 416-603-8500 ext 6237 |
| emad.alazazi@uhnresearch.ca |
- 13-6060-BE