NCT01648959

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

December 2, 2020

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

1.7 years

First QC Date

July 13, 2012

Results QC Date

May 11, 2020

Last Update Submit

December 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • iEEG Recording

    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.

    1 day

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation

You may not qualify if:

  • Lack of informed consent
  • Hypersensitivity to dexmedetomidine
  • Language barrier
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital,UHN.

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Emad Al Azazi
Organization
Toronto Western Hospital/UHN

Study Officials

  • lashmikumar venkatraghavan, MD

    Assistant professor,Toronto western hospital,university health network (UHN)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 25, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 22, 2022

Results First Posted

December 2, 2020

Record last verified: 2022-12

Locations