Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain Dynamics in Different Stages of Arousal and Anesthesia (ECOG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574443
Recruitment Status : Terminated (Feasibility issues for subject recruitment and PI left the institution)
First Posted : April 10, 2012
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date March 16, 2012
First Posted Date April 10, 2012
Last Update Posted Date November 6, 2017
Actual Study Start Date August 22, 2011
Actual Primary Completion Date May 11, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2012)
Characterization of changes in brain dynamics during induction of anesthesia, using electrocorticography (ECoG). [ Time Frame: < 1 hour ]
The patterns of electrical activity during induction and emergence from anesthesia will be compared to what is recorded during natural sleep.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: April 9, 2012)
Characterization of changes in brain dynamics during sleep, using electrocorticography (ECoG). [ Time Frame: < 1 hour ]
The patterns of electrical activity during induction and emergence from anesthesia will be compared to what is recorded during natural sleep.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Dynamics in Different Stages of Arousal and Anesthesia
Official Title Brain Dynamics in Different Stages of Arousal and Anesthesia
Brief Summary The principle aim of this project is to characterize the changes in relative stability of the intrinsic brain dynamics during onset of sleep and induction of general anesthesia. The investigators hypothesize that brain dynamics in the awake state are critical akin to physical systems close to a second order phase transition and that during loss of consciousness the dynamics move away from the critical point.
Detailed Description
  1. Once the electrode array is placed during the first surgery (on the day of admission) we will record brain activity as subjects are waking up from anesthesia
  2. While subjects are staying at New York Presbyterian hospital before the second surgery we will record brain activity. Most of the recordings will be performed as subjects are going to sleep naturally, but other recordings will be acquired during waking hours. This will not interfere with normal monitoring of seizure activity.
  3. Final recording session is immediately before the second operation as general anesthesia is gradually induced. During this time subjects may be asked to follow simple commands like: "Open your eyes" in order to determine the level of consciousness. Also during this session, if arterial line is placed by the anesthesiologist for real-time blood pressure monitoring we will collect several small (~1 ml) blood samples to determine blood concentration of anesthetics. Approximately 1 teaspoon of blood will be obtained in total. No additional venipuncture will be necessary.

No additional invasive procedures will be performed for the purposes of the study. We will use the same electrode array as is typically used for monitoring and mapping of epilepsy. Subjects will receive the same anesthetic agent as is commonly used for induction of anesthesia for this surgery (propofol). Subjects will be monitored in the same way as is normally done during surgical procedures and during your stay at New York Presbyterian hospital.

As a part of the study subjects may be asked simple questions as they go under anesthesia.

We may collect several small blood samples (described above) to determine the concentration of anesthetic agents.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing epilepsy resection surgery
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts epilepsy resection patients
Patients undergoing resection for refractory epilepsy
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: November 2, 2017)
5
Original Estimated Enrollment
 (submitted: April 9, 2012)
50
Actual Study Completion Date April 8, 2016
Actual Primary Completion Date May 11, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

1.Patients referred for epilepsy resection surgery with Dr. Theodore Schwartz

Exclusion Criteria:

  1. Patient refusal.
  2. Patients requiring rapid sequence induction because of concerns about delayed gastric emptying as a result of diabetes or other medical conditions.
  3. Age less than 15 or greater than 65 years old.
  4. Pregnant or nursing.
  5. Inability to follow simple commands such as "Open your eyes" and "Squeeze my hand" for any reason.
  6. Severe mental disability.
  7. Allergy to propofol or any components of the formulation.
  8. Poor suitability for propofol infusion because of other medical concerns such as severe heart disease.
  9. Patients deemed to have a difficult airway thus necessitating awake fiberoptic intubation.
  10. Patients with severe sleep apnea requiring CPAP/BiPAP.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01574443
Other Study ID Numbers 1106011763
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators
Principal Investigator: Kane Pryor, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date November 2017