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Population Pharmacokinetics of Remimazolam Besylate After Continuous Infusion in Liver Transplantation Patients and Renal Transplantation Patients

Population Pharmacokinetics of Remimazolam Besylate After Continuous Infusion in Liver Transplantation Patients and Renal Transplantation Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065454
Enrollment
Unknown
Registered
2022-11-04
Start date
2022-11-04
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperation Sedation

Interventions

liver transplantation group:continuous infusion of remimazolam
renal transplantation group:continuous infusion of remimazolam
non-transplant group:continuous infusion of remimazolam

Sponsors

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. BMI 19-28 kg/m2; 3. Basic blood pressure: systolic pressure 90-160 mmHg,diastolic pressure 0-100 mmHg; heart rate in peace 50-100 bpm; oxyhemoglobin saturation >= 95% 4. Liver tranplantion patients, renal transplantion patients and other postoperative patients with nomal liver function and kidney function, who's admitted to intensive care unit after suguery; 5. Sign the informed cntract.

Exclusion criteria

Exclusion criteria: 1. Marginal donor liver and liver cancer; Marginal donor kidney, renal cell carcinoma; 2. Intraoperative blood loss > 1000 ml; 3. Preoperative MELD score of liver transplantation patients > 20; 4. Hemodynamic instability during operation requires continuous use of vasoactive drugs; 5. Patients with organ dysfunction other than transplanted organs before surgery; 6. Preoperative electrocardiogram showed prolonged QT time; 7. Known allergy to any benzodiazepine, flumazenil, or study drug excipients (lactose/dextroside 40); 8. Participated in a trial of another study drug within 2 months before or during the study administration; 9. Patients in deep coma who cannot be scored subjectively; 10. Patients with metastatic cancer, affecting liver and renal function metabolism; 11. Patients with myasthenia gravis; 12. Patients who received monoamine oxidase inhibitors within 14 days; 13. Pregnant/perinatal women.

Design outcomes

Primary

MeasureTime frame
plasma concentration;

Countries

China

Contacts

Public ContactYuan Gao

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

gaoyuanzhuren@126.com+86 13651672480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026