Clinical trial NCT02386995: BIS and Entropy in Deep Brain Simulation
Official title: Comparison of Bispectral Index and Entropy Monitoring in Patients Undergoing Internalization of Deep Brain Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders
Depth of Anesthesia Monitors
Keywords: depth of anesthesia monitors
deep brain stimulation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a general anesthesia post DBS insertion for the internalization of DBS.

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.

Eligibility 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.

Primary outcomes:
measure: Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Heath Network, Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto Western Hospital
name: Lashmi Venkatraghavan
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heath Network, Toronto Western Hospital
name: Pirjo Manninen
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heath Network, Toronto Western Hospital
name: Audrey MY Tan
role: PRINCIPAL_INVESTIGATOR
References: