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Recruiting NCT07045467

Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

Phase I Interventional Chronic Kidney Diseases Renal Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remimazolam Besylate.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases, Renal Transplantation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study

Overview

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

Interventions

  • Drug Remimazolam Besylate
    This is the first clinical trial evaluating Remimazolam's pharmacokinetics (PK), pharmacodynamics (PD), and safety in renal transplant recipients-a population with unique physiological alterations due to end-stage renal disease and graft reperfusion. Key differentiators include: Population-Specific Dosing Protocol: Induction: 6 mg/kg/h until MOAA/S ≤1 (vs. 5-12 mg/kg/h in general surgery). Maintenance: Titrated (0.5-2 mg/kg/h) to Narcotrend Index 27-60 (lower than typical BIS 40-60 targets),

Primary outcome measures

  • Remimazolam Plasma Concentration [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
  • Remimazolam PK Parameters [Time frame: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes]
Secondary outcome measures (10)
  • Postoperative Urine Output [Time frame: Postoperation Days 1 to 6]
  • Serum Creatinine Level [Time frame: Preoperation, Postoperation Days 1 to 6]
  • Estimated Glomerular Filtration Rate [Time frame: Preoperation, Postoperation Days 1 to 6]
  • Intraoperative Hypotension Incidence [Time frame: Intra-operative period]
  • Intraoperative Bradycardia Incidence [Time frame: Intra-operative period]
  • Injection Pain Incidence [Time frame: During induction (0 to 10 minutes)]
  • Postoperative Nausea/Vomiting Incidence [Time frame: PACU admission to Postoperation Day 6]
  • Postoperative Agitation Incidence [Time frame: PACU stay (0 to 2 hours)]
  • Delayed Recovery Incidence [Time frame: End of surgery to PACU discharge]
  • Intraoperative Awareness Incidence [Time frame: Upon PACU discharge (Day 1)]

Eligibility criteria

Inclusion Criteria Signed informed consent

Age ≥18 years and <65 years

Chronic renal failure scheduled for renal transplantation

Body mass index (BMI) 18-30 kg/m² (inclusive)

Weight ≥50 kg (males) or ≥45 kg (females)

ASA physical status classification III or IV

Exclusion Criteria Hepatic, psychiatric, or neurological disorders

Coagulopathy

Heart failure

Respiratory failure

Long-term sedative or antidepressant use

Pregnancy or lactation

Inability to communicate or cooperate

Participation in other drug/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/inducers within 30 days prior (per Appendix 1)

Known hypersensitivity to ≥2 substances

Alcohol consumption >14 units/week within 6 months prior\*

Drug abuse history within 3 months prior

Major infection/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/donation >400 mL within 3 months prior

Blood transfusion within 1 month prior

INR >1.5, PT >ULN+4 seconds, or APTT >15×ULN

Significant bleeding history within 3 months prior

Current anticoagulant therapy

Any condition deemed unsuitable by investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shandong First Medical University Hospital — Jinan

Identifiers

NCT: NCT07045467 · YXLL-KY-2024(103)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗