N/A
N=30
BIS and Entropy in Deep Brain Simulation
Movement Disorders · Depth of Anesthesia Monitors
Bottom Line
View on ClinicalTrials.gov: NCT02386995 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices — 96; 96; 65; 77 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- BIS monitor (Device); Entropy monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Bispectral (BIS) and Response Entropy (RE) Indices |
96; 96; 65; 77; 59; 63 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02386995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.