Movement DisordersNCT02386995
BIS and Entropy in Deep Brain Simulation
An observational study of Movement Disorders and Depth of Anesthesia Monitors, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Movement Disorders, Depth of Anesthesia Monitors
- What is being tested?
- BIS monitor and Entropy monitor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Mar 2014
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a general anesthesia post DBS insertion for the internalization of DBS.
Who may be able to join
- Adult patients older than 18 years of age scheduled for elective internalisation of DBS electrodes under general anesthesia.
Who cannot join
- lack of informed consent
- language barrier
- those that are transferred to an intensive care unit postoperatively.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Heath Network, Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Comparison of Bispectral Index and Entropy Monitoring in Patients Undergoing Internalization of Deep Brain Simulation
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.
Read the 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.
- Conditions
- Movement Disorders, Depth of Anesthesia Monitors
- Being tested
- BIS monitor, Entropy monitor
- Keywords
- depth of anesthesia monitors, deep brain stimulation
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS monitorDevice
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 monitorDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BIS monitor; Device: Entropy monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lashmi Venkatraghavan, University Health Network, Toronto
- Investigators
- Lashmi Venkatraghavan, Principal investigator, University Health Network, Toronto Western HospitalPirjo Manninen, Principal investigator, University Heath Network, Toronto Western HospitalAudrey MY Tan, Principal investigator, University Heath Network, Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386995
- Sponsor's protocol ID
- 13-6060
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2013
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No