Examining the risk of awareness during surgery in patients with multiple anesthesia exposures
A Survey and Chart Review to Determine if Patients Exposed to General Anesthesia Significant Numbers of Times Would Increase the Risk for Intraoperative Awareness With Explicit Recall.
This study is trying to see if people who have had general anesthesia many times are more likely to remember things during surgery than those who haven't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05857618 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if patients who have undergone general anesthesia multiple times are at a higher risk for experiencing intraoperative awareness with explicit recall (AWR). It focuses on understanding the incidence of AWR in vulnerable populations who require frequent anesthesia. By analyzing patient experiences and outcomes, the study seeks to inform better anesthesia management practices to enhance patient safety and comfort. The research will involve assessing patients' anesthesia history and their reported experiences during surgeries.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone general anesthesia more than 20 times or 5 or fewer times within a specified timeframe.
Not a fit: Patients who are healthy volunteers or cannot recall their experiences with intraoperative awareness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia protocols that minimize the risk of intraoperative awareness, enhancing patient safety and comfort.
How similar studies have performed: Previous studies have indicated a low incidence of AWR in the general population, but this study aims to explore a potentially higher risk group, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have been exposed to general anesthesia greater than 20 times or who have been exposed to general anesthesia 5 or fewer times between January 1, 1985 and June 15, 2017 * Patients/their Guardians who consent to participate in the study. * Patients for whom a determination of AWR status can be made by anesthesiologists based on a standardized criteria. * Must be at least 7 years of age or older. Exclusion Criteria: * Healthy volunteers, * Patients who cannot recall whether or not they have experienced intraoperative awareness with explicit recall
Where this trial is running
Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Zheng Xie, MD, PhD
- Email: jxie@dacc.uchicago.edu
- Phone: 773-702 2667
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.