- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01648959
Intra Cranial EEG Activity During Dexmedetomidine Sedation
December 20, 2022 updated by: Lashmi Venkatraghavan, University Health Network, Toronto
Intra Cranial EEG Activity During Dexmedetomidine Sedation.Comparing the Effects of Dexmedetomidine on the Cortical and the Sub Cortical(Hippocampus) Structures.
Various parts of the brain are sensitive to various anesthetics.We like to study the effect of dexmedetomidine on the different parts of the brain in patients who are coming for DBS electrode removal under sedation.
Study Overview
Detailed Description
Cortical and sub cortical structures will have different sensitivities to various anesthetics.The objective of this study is to look at the changes in the intracranial electroencephalographic (EEG) characteristics during dexmedetomidine sedation and to determine the differences in the EEG characteristics between cortical and subcortical structures.
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T2S8
- Toronto Western Hospital,UHN.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation
Description
Inclusion Criteria:
- Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation
Exclusion Criteria:
- Lack of informed consent
- Hypersensitivity to dexmedetomidine
- Language barrier
- Emergency surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iEEG Recording
Time Frame: 1 day
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iEEG data from each patient was analyzed using MATLAB (Natick, MA, USA).
Data were presented as power spectral density, also referred to as the power spectrum or spectrum which quantifies the frequency distribution of energy or power within a signal.
The spectrogram is a time-varying version of the spectrum.
In these spectrograms, frequencies are arranged along the y-axis, and time along the x-axis, and power is indicated by color on a decibel (dB) scale.
The power spectrum was computed for each channel using The Fast Fourier Transform (FFT).
A window length of 20,000 data points was chosen in order to incorporate 4 cycles of a 1 Hz signal.
The length of each window was therefore 4 seconds.
A Hanning window was used to avoid edge effects of the windowing procedure.
The length of the FFT was chosen to be 32768, which is the next power of 2 of the window length.
The window overlap was set to zero.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: lashmikumar venkatraghavan, MD, Assistant professor,Toronto western hospital,university health network (UHN)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
July 13, 2012
First Submitted That Met QC Criteria
July 23, 2012
First Posted (Estimate)
July 25, 2012
Study Record Updates
Last Update Posted (Actual)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 20, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-0268
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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