Monitoring awareness and pain during anesthesia using EEG technology
Monitoring Awareness and Pain Under Anesthesia Using a New EEG Based System
Rambam Health Care Campus · NCT02938325
This study is testing a new EEG system to see if it can help doctors monitor patients' awareness and pain during surgery while they're under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rambam Health Care Campus (other) |
| Locations | 1 site (Haifa) |
| Trial ID | NCT02938325 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor patients' awareness and pain levels during general anesthesia using a novel EEG-based system. It focuses on understanding the phenomenon of 'awareness under anesthesia,' where patients may be conscious but unable to communicate due to paralysis. The study will involve patients undergoing elective surgeries and healthy volunteers who will be monitored with EEG and BIS technology. Participants will complete a questionnaire post-procedure to assess their experiences.
Who should consider this trial
Good fit: Ideal candidates include patients classified as ASA 1-3 undergoing elective surgeries under general anesthesia or sedation.
Not a fit: Patients requiring emergent surgeries or those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient safety by reducing the incidence of awareness under anesthesia and improving anesthetic practices.
How similar studies have performed: While awareness under anesthesia has been a topic of concern, this specific EEG-based monitoring approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Haifa
- Rambam Health Care Campus — Haifa, Israel (RECRUITING)
Study contacts
- Principal investigator: Dana Baron Shahaf, MD PhD — Rambam Health Care Campus
- Study coordinator: Dana Baron Shahaf, MD PhD
- Email: dana_bs@rambam.health.gov.il
- Phone: 972-4-7772487
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Awareness Under Anesthesia, Electroencephalogram, awareness