The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients

The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-label, Controlled Trial

This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol.

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 lactation period;
• Enrolled in other clinical trails in recent 3 months;
• Other circumstance that identified by researchers that do not suitable for this clinical trial.