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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Yichang Humanwell Pharmaceutical Co.,Ltd
• Treatments: Propofol

Criteria

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.