Skip to content

Protective effects of continuous infusion of Remazolam toluene sulfonate on transplanted liver of orthotopic liver transplantation: a prospective, randomized, controlled study

Protective effects of continuous infusion of Remazolam toluene sulfonate on transplanted liver of orthotopic liver transplantation: a prospective, randomized, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040583
Enrollment
Unknown
Registered
2020-12-03
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

end-stage liver disease

Interventions

Remazolam toluene sulfonate group (S group):The experimental drug in the intervention group was Ruimazolam for injection of toluene sulfonic acid(Ruiming, Hengrui, Jiangsu)
Blank control (C group ):The drug used in the control group was normal saline blank controll.

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18-65 years old; 2) Body mass index (BMI) 18 ~ 30 kg/m; 3) ASA classification Level I~III; 4) Proposed orthotopic liver transplantation; 5) Sign the informed consent.

Exclusion criteria

Exclusion criteria: Receptor exclusion criteria: 1) Poor preoperative glycemic control (HbA1c>8.5%); 2) MELD score> 30; 3) Severe cardiopulmonary diseases; 4) Unsteady Preoperative hemodynamics; 5) Preoperative life support (mechanical ventilation, renal replacement therapy, etc.); 6) Severe infection; 7) Anaesthesia drug allergy and patient refusal. Donor liver exclusion criteria: 1) Elderly donors (age>65 years old); 2) History of diabetes of the donors; 3) Preoperative serum sodium level of donors>155 mmol/L; 4) Preoperative AST or ALT level of donors>100 U/L; 5) Length of ICU stay of donors> 7 days; 6) Hemodynamic instability of the donors: systolic blood pressure 10 ug/(kg.min); 7) Steatotic donor liver (bullae steatosis >=30%); 8) Uncontrolled cardiac death donor (uDCD);9) Graft cold ischemia time> 16 h; 10) Graft hot ischemia time> 90 min; 11) Partial graft (reduced volume or split donor liver).

Design outcomes

Primary

MeasureTime frame
Albumin-bilirubin (Albumin-bilirubin, ALBI) score;

Secondary

MeasureTime frame
ALT;AST;ALB;TBIL;PT;IL-1b;IL-6;IL-8;IL-10;TNF-alpha;CRP;Serum adrenaline;Serum norepinephrine;Serum cortisol;blood glucose;NK cell count;B cell count;CD3 + T cell count;CD4 + T cell count;CD8 +T cell count;The ratio of CD4 +:CD8 +;The ratio of Th 1:Th2;cumulative duration of new hepatic hypotension (MAP<60mmHg);The total dose of norepinephrine used;Liquid inflow and outflow;Use of blood products;Postoperative offline extubation time;Postoperative ICU stay days;Postoperative hospitalization days;The incidence of serious adverse reactions within 30 days after surgery;

Countries

China

Contacts

Public ContactGao Zhifeng

Beijing Tsinghua Changgung Hospital

gzfa02461@btch.edu.cn+86 15801249466

Outcome results

None listed

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