Clinical trial NCT04947345: The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Analgesia
Postoperative Pain
Keywords: sedative
Remimazolam Besylate
postoperative sedation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Yichang Humanwell Pharmaceutical Co., Ltd., China
First posted: 2021-07-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Satisfaction rate of sedation
timeFrame: 24 hours since injection of sedatives
measure: Rate of major clinical events
timeFrame: 48 hours since injection of sedatives
Secondary outcomes:
measure: incidence of delirium
timeFrame: 48 hours since injection of sedatives
measure: Time to weaning and extubation
timeFrame: 48 hours since injection of sedatives
measure: Difficulty of nursing
timeFrame: 48 hours since injection of sedatives
measure: 28-days survival
timeFrame: 28 days since injection of sedatives
measure: incidence of rescue therapy in experimental group
timeFrame: 24 hours since injection of sedatives
Other outcomes:
Locations:
Study officials:
References:
citation: Liu S, Su L, Zhang B, He H, Li Z, Li Q, Wang Q, Smith F, Long Y. 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. Front Med (Lausanne). 2021 Nov 5;8:735473. doi: 10.3389/fmed.2021.735473. eCollection 2021.