Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive … (NCT04601350) | Clinical Trial Compass
CompletedNot Applicable
Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
China80 participantsStarted 2020-11-01
Plain-language summary
Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the effects of remimazolam on EEG and postoperative cognitive function ，in order to further understand the clinical application of remimazolam.
Who can participate
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:
* ASAⅠ-Ⅱ
* Patients undergoing elective surgery under general anesthesia.
* Age, sex, and weight were not limited.
Exclusion Criteria:
* Allergic or contraindication to remimazolam/midazolam/remifentanil;
* Abnormal liver and kidney function; Alcohol abuse;
* Long-term use of sedative, analgesic or anxiolytic drugs;
* Hearing and language communication disorders;
* Complicated with severe cardiovascular lesions or neurological diseases.
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
The average intraoperative power spectral density in the frontal alpha band
Timeframe: Preoperatively, During operation，End of operation
2
Changes in the score of MMSE
Timeframe: The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery