Clinical trial NCT03835156: Introducing a New EEG Based Index for Monitoring Recall Under Sedation
Official title: Introducing a New EEG Based Index for Monitoring Recall Under Sedation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recall Phenomenon
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identification recall, using the new A/P index, in sedated patients
timeFrame: 2 years
Secondary outcomes:
measure: Identification recall, using a prefrontal based electrophysiological method (BIS) in sedated patients
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: