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

• ClinicalTrials.gov Identifier: NCT01574443
• Recruitment Status: Terminated
• First Posted: April 10, 2012
• Last Update Posted: November 6, 2017
• Sponsor: Weill Medical College of Cornell University
• 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
• 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

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

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