Introducing a New EEG Based Index for Monitoring Recall Under Sedation

• Conditions: Recall Phenomenon

• Registration Number: NCT03835156
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13
• Study Start: 2019-04-01
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Research group:

1. Patients old 18-80 years

2. ASA I-III criteria

3. Patients undergoing sedation for lithotripsy

   Control groups -

4. Control general anesthesia group - Patients ASA I-III criteria, undergoing general anesthesia for general surgery

5. Control awake group - Awake healthy volunteers,

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification recall, using the new A/P index, in sedated patients	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Identification recall, using a prefrontal based electrophysiological method (BIS) in sedated patients	2 years	Comparing the ability of BIS index to identify patients with recall under sedation, to the new A/P index