Intra Cranial EEG Activity During Dexmedetomidine Sedation

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01648959
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Partial Seizures	Other: EEG Recording

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 Design

• Study Type: Observational
• Actual Enrollment: 5 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intra Cranial EEG Activity During Dexmedetomidine Sedation.Comparing the Effects of Dexmedetomidine on the Cortical and the Sub Cortical(Hippocampus) Structures.
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Outcome Measures

Primary Outcome Measures

1. iEEG Recording [1 day]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital,UHN.	Toronto	Ontario	Canada	M5T2S8

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

• Principal Investigator: lashmikumar venkatraghavan, MD, Assistant professor,Toronto western hospital,university health network (UHN)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lashmi Venkatraghavan, Dr., University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01648959
• Other Study ID Numbers: 12-0268-B
• First Posted: Jul 25, 2012
• Last Update Posted: Dec 2, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Seizures

Study Results

Participant Flow

Arm/Group Title	iEEG Activity
Arm/Group Description	iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dexmedetomidine Infusion and iEEG Activity
Arm/Group Description	5 patients included in this study underwent bi-temporal implantation, and were shown to have unilateral hippocampal seizure onsets. iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.
Overall Participants	5
Age, Customized (years) [Mean (Standard Deviation) ]
Age	37.3 (7.0)
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	iEEG Recording
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iEEG Activity
Arm/Group Description	Data are 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.
Measure Participants	5
Mean (Full Range) [(Hz)]	8

Adverse Events

Time Frame	From the time of induction to the end of surgical procedure
Adverse Event Reporting Description	No adverse events reported
Arm/Group Title	iEEG Activity
Arm/Group Description	iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.
All Cause Mortality
	iEEG Activity
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	iEEG Activity
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	iEEG Activity
	Affected / at Risk (%)	# Events
Total	0/5 (0%)

Limitations/Caveats

[Not Specified]

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.