Intra Cranial EEG Activity During Dexmedetomidine Sedation

Tracking Information
First Submitted Date	July 13, 2012
First Posted Date	July 25, 2012
Last Update Posted Date	February 6, 2018
Study Start Date	July 2012
Actual Primary Completion Date	March 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: February 9, 2015)	EEG Recording [ Time Frame: 1 day ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01648959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Intra Cranial EEG Activity During Dexmedetomidine Sedation
Official Title	Intra Cranial EEG Activity During Dexmedetomidine Sedation.Comparing the Effects of Dexmedetomidine on the Cortical and the Sub Cortical(Hippocampus) Structures.
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.
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
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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
Condition	EEG Effect of Dexmedetomidine on the Cortical and Subcortical Structures
Intervention	Other: EEG Recording
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Terminated
Actual Enrollment; (submitted: July 23, 2012)	20
Original Estimated Enrollment	Same as current
Actual Study Completion Date	March 2014
Actual Primary Completion Date	March 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Canada
Removed Location Countries
Administrative Information
NCT Number	NCT01648959
Other Study ID Numbers	12-0268-B
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Lashmi Venkatraghavan, University Health Network, Toronto
Study Sponsor	University Health Network, Toronto
Collaborators	Not Provided
Investigators	Principal Investigator: lashmikumar venkatraghavan, MD Assistant professor,Toronto western hospital,university health network (UHN)
PRS Account	University Health Network, Toronto
Verification Date	February 2018