Actively Recruiting
Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
Led by Qianfoshan Hospital · Updated on 2025-10-01
30
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of remimazolam (CNS 70754) in healthy adult participants. The main questions it aims to answer are: What are the key pharmacokinetic parameters of remimazolam, including peak concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and elimination half-life (T1/2)? What is the effect of remimazolam on consciousness, as measured by the MOAA/S scale and Narcotrend monitoring during anesthesia? Researchers will compare the pharmacokinetic and pharmacodynamic effects of remimazolam to see if the drug provides consistent and predictable sedation without significant adverse effects. Participants will: Receive continuous Infusion of Remimazolam. Have blood samples taken at various time points to measure plasma concentrations and calculate PK parameters. Be monitored for consciousness and sedation levels using the MOAA/S scale and Narcotrend. Undergo safety assessments, including laboratory tests, vital signs monitoring, and physical examinations throughout the study. This study will help determine the drug's behavior in the body and its impact on sedation, providing valuable information for its future clinical use in anesthesia and other medical applications. Last updated on December 22, 2024
CONDITIONS
Official Title
Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older and under 65 years
- Chronic renal failure scheduled for kidney transplantation
- Body mass index (BMI) between 18 and 30 kg/m²
- Weight 50 kg or more for males, or 45 kg or more for females
- ASA physical status classification III or IV
You will not qualify if you...
- Presence of hepatic, psychiatric, or neurological disorders
- Coagulopathy
- Heart failure
- Respiratory failure
- Long-term use of sedatives or antidepressants
- Pregnancy or breastfeeding
- Inability to communicate or cooperate
- Participation in other drug or device trials within 3 months prior
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis antibody
- Use of liver enzyme inhibitors or inducers within 30 days prior
- Known allergy to two or more substances
- Alcohol consumption exceeding 14 units per week within 6 months prior
- History of drug abuse within 3 months prior
- Major infection or trauma within 1 month prior
- Gastrointestinal surgery affecting drug absorption within 1 month prior
- Vaccination within 1 month prior or planned during study
- Blood loss or donation over 400 mL within 3 months prior
- Blood transfusion within 1 month prior
- Abnormal blood clotting tests (INR >1.5, PT >ULN+4 seconds, or APTT >15×ULN)
- Significant bleeding history within 3 months prior
- Current anticoagulant therapy
- Any condition the investigator considers unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong First Medical University Hospital
Jinan, Shangdong, China, 250014
Actively Recruiting
Research Team
G
guanghan wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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