The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients (NCT04947345) | Clinical Trial Compass
UnknownPhase 3
The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients
84 participantsStarted 2021-09-01
Plain-language summary
This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Meet criteria of enhanced recovery after surgery (ERAS);
* Mechanical ventilated when enrolled and have estimation of more than 10 hours of mechanical ventilation in ICU
* Aged between 18-75 years old AND 18kg/m2 ≤ BMI ≤ 30 kg/m2;
* Clearly know the purpose and objective of this clinical study and voluntarily enrolled.
Criteria of ERAS: (1) without dysfunction of nervous system or Glasgow Coma Score \> 12; (2) a satisfied glucose level (random blood glucose\<11.1mmol/L during screening stage) for diabetes mellitus patients; (3) Without acute coronary syndrome in recent 6 months; (4) Without bradycardia and third-degree atrioventricular block (except for patients with pacemaker) during screening stage; (5) systolic blood pressure\>90mmHg with no usage of vasoactive agent during screening stage; (6) without mental illness (schizophrenia, depressive disorder), cognitive dysfunction (identified by MMSE), epilepsy, history of abuse of psychotropic or anesthesia medication; (7) without disorder of coagulation function (PT/INR/APTT \> 1.5×upper limit), bleeding tendency (active peptic ulcer), under treatment of thrombolysis and anticoagulant; (8) without disorder of liver function (ALT/AST \> 2×upper limit and total bilirubin\>1.5×upper limit); (9) without disorder of renal function (Creatine or BUN/Urea\>1.5×upper limit); without dialysis patients.
Exclusion criteria
* Allergy to component of Remimazolam besylate for injection;
* Woman in gestation and lact…