The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate (NCT06427785) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate
30 participantsStarted 2024-08-15
Plain-language summary
To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
Who can participate
Age range
18 Years – 65 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:
* ASA was classified as I-III
* The operation time was less than 120 minutes
* Informed consent is signed by all study participants
* Elective lower extremity surgery under spinal anesthesia was performed
Exclusion Criteria:
* Pregnant or lactating women
* Patients with Difficult Airways
* History of severe neurological and muscular diseases and mental retardation
* Patients with severe respiratory and circulatory diseases, including acute heart failure. Unstable angina pectoris. Resting ECG heart rate \<50 beats/min. QTc: ≥470ms in men and ≥480ms in women. Third degree atrioventricular block. Severe arrhythmia. Moderate to severe heart valve disease. Chronic obstructive pulmonary disease. A history of severe asthma.
* Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
* Take diazole drugs and/or opioids in one month or nearly three months
* Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
* Patients who could not monitor the depth of anesthesia for various reasons
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 value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1.
Timeframe: Through study completion, an average of 1 day