Actively Recruiting
Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study
Led by Qianfoshan Hospital · Updated on 2025-10-01
30
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug affects the body) of remimazolam in adults undergoing kidney transplant surgery. This trial focuses on understanding key drug parameters such as peak concentration, time to peak, area under the curve, and elimination half-life. It also measures the drug's impact on consciousness using the MOAA/S sedation scale and Narcotrend monitoring during anesthesia. Participants will receive continuous intravenous infusion of remimazolam besylate following a specific anesthesia protocol for renal transplant surgery. The induction dose is 6 mg/kg/h until loss of consciousness, followed by a maintenance dose titrated between 0.5 and 2 mg/kg/h to maintain the target anesthesia depth. Additional medications like analgesics, muscle relaxants, and immunosuppressants are given according to protocol, while common sedatives such as midazolam and propofol are avoided. During the study, participants will have blood samples collected at multiple time points before, during, and after infusion to analyze drug levels and metabolism. Sedation depth will be regularly assessed using MOAA/S and continuous Narcotrend monitoring. Safety evaluations include lab tests, vital signs, and physical exams. Researchers will track various outcomes such as urine output, kidney function, and possible adverse events through the surgery and up to six days post-operation.
CONDITIONS
Brief 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 less than 65 years
- Chronic renal failure scheduled for renal transplantation
- Body mass index (BMI) between 18 and 30 kg/m² inclusive
- 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...
- Hepatic, psychiatric, or neurological disorders
- Coagulopathy
- Heart failure
- Respiratory failure
- Long-term use of sedatives or antidepressants
- Pregnancy or lactation
- Inability to communicate or cooperate
- Participation in other drug or device trials within 3 months prior
- Positive hepatitis B surface antigen (HBsAg)
- Positive hepatitis C antibody (HCV-Ab)
- Positive HIV antibody
- Positive syphilis antibody
- Use of hepatic enzyme inhibitors or inducers within 30 days prior
- Known hypersensitivity to 2 or more substances
- Alcohol consumption greater than 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 greater than 400 mL within 3 months prior
- Blood transfusion within 1 month prior
- INR greater than 1.5, PT greater than upper limit of normal plus 4 seconds, or APTT greater than 15 times the upper limit of normal
- Significant bleeding history within 3 months prior
- Current anticoagulant therapy
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of kidney transplant surgery
Participants receive a continuous infusion of Remimazolam Besylate during kidney transplant surgery with dosing adjusted based on sedation depth. Ancillary medications and monitoring occur throughout surgery.
1 surgery day visit (in-person)
Duration - 6 days after surgery
Participants are monitored for safety and kidney function through post-operative days 1 to 6 with urine output and blood tests.
Daily visits or assessments for 6 days post-operation
Trial Site Locations
Total: 1 location
1
Shandong First Medical University Hospital
Jinan, Shangdong, China, 250014
Actively Recruiting
Research Team
G
guanghan wu
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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