Introducing a New EEG Based Index for Monitoring Recall Under Sedation

NCT03835156 | Unknown

• 1 other identifier: REB 18-308
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single centre prospective observational study that will investigate a new EEG based index in recognizing recall of anesthesia in sedated patients. Awareness under general anesthesia is a dreadful complication. Various EEG-based technologies (such as BIS and others) were developed in order to identify this condition during anesthesia, using an EEG sticker on the forehead measuring the frontal EEG activity. However, these monitors might be inaccurate due to lack of sensitivity to various hypnotic agents as well as sensitivity to muscle activity, which might lead to report of deep anesthesia in the awake patient. Due to the very low prevalence of awareness under general anesthesia it is difficult to validate or invalidate the effectiveness of these monitors directly. Nevertheless, sedation often involves much greater prevalence of awareness, which permits to evaluate identification of recalled awareness with much humbler sample size. The current available depth of anesthesia EEG based monitors are not effective in sedated patients since they are susceptible to muscle activity effect, which is present under sedation. Based on the current literature in the field of electrophysiology the investigators have developed the anterior/ posterior (A/P) index (in the range of 0-100) for appreciating the anesthetic level. It is based on a comparison of anterior brain activity levels to posterior brain activity levels in response to anesthetic medication. The novelty of the index is stem from the fact that it is based on analyzing EEG data from only 4 electrodes covering the frontal and posterior brain activity. The investigators have shown in a proof of concept study performed in Rambam Hospital, Haifa, Israel that this index is not dependent on muscle activity thus is the only index that can identify recall in sedated patients.

Conditions

Recall Phenomenon

Outcome Measures

Primary Outcomes (1)

• Identification recall, using the new A/P index, in sedated patients

  In this new following study, the investigators suggest to repeat the proof of concept study performed in Rambam Hospital, Israel (NIH trial registration: NCT02938325), with an FDA approved EEG system, with much better signal-to-noise ratio in order to demonstrate the ability to monitor awareness at the 30-seconds resolution scale. The objective of this study will be to demonstrate that the A/P index, which is generated with an FDA approved EEG system, would relate to recall of awareness in sedation, with a better signal to noise ratio whereas a prefrontal based electrophysiological method (BIS) would not relate to recall.

  2 years

Secondary Outcomes (1)

• Identification recall, using a prefrontal based electrophysiological method (BIS) in sedated patients

  2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants will receive detailed oral and printed information about the study and will sign a written informed consent form prior to study enrollment. Enrollment in the study is entirely voluntary, and declining to participate will in no way affect the quality or quantity of care provided to patients. Patients will have the right to withdraw from the study at any time.

You may qualify if:

• Research group:
• Patients old 18-80 years
• ASA I-III criteria
• Patients undergoing sedation for lithotripsy
• Control groups -
• Control general anesthesia group - Patients ASA I-III criteria, undergoing general anesthesia for general surgery
• Control awake group - Awake healthy volunteers,

You may not qualify if:

• Lack of informed consent, Age \> 80 years, Age \< 18 years pregnant women patients who do not comply with ASA I-III criteria.

Sponsors & Collaborators

• Unity Health Toronto: lead

Central Study Contacts

Andrea Rigamonti, MD

CONTACT

416-864-5825; RigamontiA@smh.ca

Nikhil Mistry, MA

CONTACT

416-864-6060; MistryNi@smh.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medical Director, Trauma Neuro-ICU

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 8, 2019
• Study Start: April 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: March 13, 2019

Record last verified: 2019-03