Study to Determine if Patients Exposed to General Anesthesia Significant Numbers of Times Would I… (NCT05857618) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study to Determine if Patients Exposed to General Anesthesia Significant Numbers of Times Would Increase the Risk for Intraoperative Awareness.
United States1,000 participantsStarted 2017-07-19
Plain-language summary
This study will detect whether prior exposure to general anesthesia multiple times is associated with an increased incidence of awareness with explicit recall (AWR). This is especially important because patients who need to undergo multiple events of general anesthesia are medically some of the most vulnerable populations. The study hypothesizes that patients with significant exposure to general anesthesia have a higher incidence of AWR. This study may help clinicians and patients to better understand how to manage anesthesia care so that the safety and comfort of patients can be improved.
Who can participate
Age range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Awareness with Explicit Recall for patients who underwent more than 20 general anesthesia events