Analgesia, Postoperative Pain
Conditions
Keywords
sedative, Remimazolam Besylate, postoperative sedation
Brief summary
This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol.
Interventions
DRUGRemimazolam Besylate
Remimazolam Besylate are used as sedatives for subjects in this arm.
DRUGPropofol
Propofol are used as sedatives for subjects in this arm.
Sponsors
Yichang Humanwell Pharmaceutical Co., Ltd., China
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is a open label clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction rate of sedation | 24 hours since injection of sedatives | (number of subjects that meets satisfied RASS score under prescribed dose of sedative agents during study / total number of subjects) ×100% |
| Rate of major clinical events | 48 hours since injection of sedatives | (number of subjects that suffer from major clinical events during study / total number of subjects) ×100%. Major clinical events are defined as cardiac arrest, malignant arrhythmia, new onset of shock, new onset of sepsis and respirate failure unrelated to primary illness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulty of nursing | 48 hours since injection of sedatives | By Barthel index assessment |
| incidence of delirium | 48 hours since injection of sedatives | (subjects with delirium / total number of subjects ×100%) by 12h and 24h after entering ICU |
| incidence of rescue therapy in experimental group | 24 hours since injection of sedatives | (number of subjects that receive rescue therapy in experimental group/ total number of subjects) ×100% |
| 28-days survival | 28 days since injection of sedatives | (number of subjects that alive in 28-days since ICU entry/ total number of subjects) ×100% |
| Time to weaning and extubation | 48 hours since injection of sedatives | Time to weaning and extubation |
Contacts
Primary ContactLongxiang Su, M.D.
Backup ContactShengjun Liu, M.D.
Outcome results
None listed