Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

Not Applicable

Not yet recruiting

• Conditions: Renal Transplantation; Chronic Kidney Diseases
• Interventions: Drug: Remimazolam Besylate

• Registration Number: NCT07045467
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-22
• Last Update Submitted: 2025-06-22
• Study Start: 2025-07-01
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All enrolled participants receive Remimazolam Besylate via continuous IV infusion	Remimazolam Besylate	All enrolled participants receive a standardized Remimazolam Besylate-based anesthesia protocol for renal transplant surgery, as follows: 1. Intervention Drug: ◦ Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg/vial) reconstituted with sterile water. 2. Dosing Regimen: * Induction: Continuous IV infusion at 6 mg/kg/h until loss of consciousness (defined as MOAA/S score ≤1). * Maintenance: Titrated IV infusion (0.5-2 mg/kg/h) to maintain target anesthesia depth (Narcotrend Index: 27-60) until end of surgery. 3. Ancillary Medications (per protocol §7.2): * Analgesia: Sufentanil (0.4-0.5 μg/kg induction; 10 μg at peritoneum closure) + Remifentanil infusion intraoperatively. * Muscle Relaxant: Rocuronium (0.6 mg/kg induction; 0.15 mg/kg bolus PRN). * Immunosuppression: Methylprednisolone 750 mg + Furosemide 60 mg pre-reperfusion. * Prohibited Agents: Sevoflurane, propofol, midazolam, dexmedetomidine, or etomidate. 4. Depth Monitoring: * Real-time Narcot

Primary Outcome Measures

Name	Time	Method
Remimazolam Plasma Concentration	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.	Blood concentration (ng/mL) of Remimazolam
Remimazolam PK Parameters	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	Percentage of AUC Extrapolated
CNS 7054 (Metabolite) PK Parameters	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.	Percentage of AUC Extrapolated
Time to Loss of Consciousness (MOAA/S ≤1)	0 to 10 minutes after infusion start	Time from infusion start to first MOAA/S score ≤1
Sedation Depth (PD)	Induction: every 1minutes until MOAA/S≤1; Maintenance: every 10 minutes; Recovery: every 2 minutes until 3 consecutive MOAA/S=5.	MOAA/S score (0 to 5) + Narcotrend Index (NCI 0 to 100)
Time to Full Alertness (3 consecutive MOAA/S=5)	Time from infusion stop to sustained alertness	Time from infusion stop to sustained alertness
Narcotrend Index (NCI) Values	Continuous monitoring during infusion + 30 min post-stop	Anesthesia depth index (0-100 scale)

Secondary Outcome Measures

Name	Time	Method
Intraoperative Awareness Incidence	Upon PACU discharge (Day 1)	Positive Brice questionnaire response
Postoperative Urine Output	Postoperation Days 1 to 6	24-hour urine volume
Serum Creatinine Level	Preoperation, Postoperation Days 1 to 6	Blood creatinine concentration
Estimated Glomerular Filtration Rate	Preoperation, Postoperation Days 1 to 6	Kidney filtration rate
Intraoperative Bradycardia Incidence	Intra-operative period	HR \<45 bpm for \>1 min
Postoperative Nausea/Vomiting Incidence	PACU admission to Postoperation Day 6	Postoperative Nausea/Vomiting occurrence
Intraoperative Hypotension Incidence	Intra-operative period	MAP \<65 mmHg for \>1 minute
Injection Pain Incidence	During induction (0 to 10 minutes)	Participant-reported pain during drug administration
Postoperative Agitation Incidence	PACU stay (0 to 2 hours)	RASS score ≥2
Delayed Recovery Incidence	End of surgery to PACU discharge	Extubation time \>30 min post-surgery

Trial Locations

Locations (1)

Shandong First Medical University Hospital; 🇨🇳 Jinan, shangdong, China