Introducing a New EEG Based Index for Monitoring Recall Under Sedation

NCT ID: NCT03835156

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Andrea Rigamonti

Assistant Professor, Medical Director, Trauma Neuro-ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Andrea Rigamonti, MD

Role: CONTACT

RigamontiA@smh.ca

416-864-5825

Nikhil Mistry, MA

Role: CONTACT

MistryNi@smh.ca

416-864-6060 ext. 42698

Other Identifiers

REB 18-308

Identifier Type: -

Identifier Source: org_study_id