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Monitoring Awareness and Pain Under Anesthesia Using a New EEG Based System

Monitoring Awareness and Pain Under Anesthesia Using a New EEG Based System

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02938325
Enrollment
90
Registered
2016-10-19
Start date
2017-01-01
Completion date
2024-12-31
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Awareness Under Anesthesia

Keywords

Electroencephalogram, awareness

Brief summary

General anesthesia (GA) is the process of induction of unconsciousness in order to undergo surgery. Unlike sleep, a process of anesthesia is not related at all, 'Sleep' and does not include dreams - but is done by using drugs that cause a kind of unconsciousness control. The induction of GA includes combination of drugs - for sleep (inhalation anesthesia or hypnotic drugs intravenously), analgesia (opiates) and muscle relaxants. Since most of our patients paralyzed during surgery, the anesthesiologists have no way of knowing whether our paralyzed patient is asleep or awake. If the patient is awake and paralyzed, a situation named awareness under anesthesia it can cause him a traumatic experience that would leave him a cripple for his whole life. There are many stories about patients who lay paralyzed, awake, while been operated, who remembered every word of what happened during the operation and of course could not mark the anesthetist that they are awake. The anesthesiologist might suspect that his patient is awake and paralyzed through signals from the sympathetic nervous system - for example the increase in heart rate and blood pressure. But many of our patients receive different medications (eg, beta-receptor blockers that does not allow the rise of a pulse) obscuring the clinical signs, so that the patient is awake and paralyzed without being noticed by the anesthesiologist. Some patients are at a higher risk to suffer from awareness under anesthesia, because the anesthesiologist cannot provide enough anesthesia, due to their medical condition, for example: women in caesarean section under GA, patients in cardiac surgery or injured trauma patients. Twenty years ago, an EEG based tool, naming BIS was developed. Nowadays, BIS monitor's credibility is questionable 1. The effect of different hypnotic drugs is not uniform. 2. Recently it was shown that a paralyzed patient BIS index could fall mimicking a situation of a sleep - enabling a paralyzed patient being awake. Thus, it is not clear whether the calculation of the BIS monitor is based on physiological models that define what is consciousness, loss of consciousness and how consciousness arises. It seems that the BIS is only suitable for certain drugs - not as a general monitor for the level of anesthesia. The purpose of the present study is to develop a universal system for determining awareness under GA using an innovative algorithm for analyzing EEG waves, based on the physiological processes of attention and perception underlying the basis for sedation and GA.

Interventions

None listed

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* ASA 1-3 * Patients for elective surgery under general anesthesia or elective procedures under sedation (such as cardiac electrical studies, liver chemo-embiolization, biliary tract drainage) * The willing of the patient to fulfil the Modified Brice Questionnaire at the end of the procedure in recovery unit * Healthy volunteers that will accept to be monitored with EEG and BIS for 10 minutes in supine position, as control.

Exclusion criteria

* Lack of consent * Emergent surgery Emergent procedure (catheterization)

Design outcomes

Primary

MeasureTime frameDescription
Could a new EEG based Posteriorization/Anteriorization (P/A) index identify recall under sedationImmediately after surgeryPosteriorization/ Anteriorizatio index is analyzed at the end of the surgery, with no influence on the intraoperative treatment of the patient.

Secondary

MeasureTime frameDescription
The association between the P/A index to muscle activitySub- analysis, within 6 months from the date the last patient was recruited for the studyThe correlation between the electromyelograph (EMG) activity, to the calculated index
The association between BIS to muscle activitySub- analysis, within 6 months from the date the last patient was recruited for the studyThe correlation between the electromyelograph (EMG) activity, to BIS
Could Bis identify recall under sedationImmediately after surgeryBIS index is recorded during the procedure, but the anesthesiologists is blinded to its results. The association between BIS and recall is analyzed at the end of the surgery.

Countries

Israel

Contacts

Primary ContactDana Baron Shahaf, MD PhD
dana_bs@rambam.health.gov.il972-4-7772487
Backup ContactGoded Shahaf, MD PhD
godeds@gmail.com972-4-8102883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026