PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Ren… (NCT06153498) | Clinical Trial Compass
CompletedNot Applicable
PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function
China36 participantsStarted 2023-11-04
Plain-language summary
Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters and adverse events.
Who can participate
Age range
18 Years – 80 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:
* Age ≥18 and ≤80 years, regardless of gender;
* Anticipated requirement for mechanical ventilation and sedation ≥24 hours;
* arget sedation level within RASS score range of -3 to 0 (inclusive);
Patients with renal impairment were defined as having a glomerular filtration rate (GFR) \<90 mL/min/1.73m². Patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2
Exclusion Criteria:
* BMI\<18 or \>30kg/m2;
* Hypersensitivity to study drugs/opioids/reversal agents;
* Life expectancy \<48 hours;
* Scheduled surgery requiring general anesthesia within 24h;
* Myasthenia gravis;
* Moderate-severe hepatic impairment (Child-Pugh ≥B);
* Severe CKD (eGFR \<30 mL/min/1.73m²) or renal replacement therapy within 3 days;
* Recent benzodiazepine use (≤1 week) or chronic benzodiazepine dependence;
* Hemodynamic instability (≥2 vasopressors to maintain SBP \>90 mmHg);
* Inability to perform RASS assessment (e.g., major neuropsychiatric disorders, coma);
* Pregnancy/lactation;
* Acute coronary syndrome or severe cardiac dysfunction (LVEF ≤30%, advanced heart block, HR\<50 bpm without pacing);
* Active ECMO/IABP support; Substance abuse history (≤2 years)。
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
Cmax
Timeframe: Within 24 hours while receiving the study drug
2
The area under the plasma drug concentration-time curve
Timeframe: Within 24 hours while receiving the study drug
3
t1/2
Timeframe: Within 24 hours while receiving the study drug
Trial details
NCT IDNCT06153498
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology