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

Study Description

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.

Condition or disease
Epilepsy

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 Design

• Study Type: Observational
• Actual Enrollment: 5 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Brain Dynamics in Different Stages of Arousal and Anesthesia
• Actual Study Start Date: August 22, 2011
• Actual Primary Completion Date: May 11, 2015
• Actual Study Completion Date: April 8, 2016

Groups and Cohorts

Group/Cohort
epilepsy resection patients; Patients undergoing resection for refractory epilepsy

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing epilepsy resection surgery

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.

Contacts and Locations

Locations

United States, New York

New York Presbyterian Hospital/ Weill Cornell Medical College

New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

• Principal Investigator: Kane Pryor, MD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01574443
• Other Study ID Numbers: 1106011763
• First Posted: April 10, 2012
• Last Update Posted: November 6, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:

Epilepsy

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases