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| Name | Class |
|---|---|
| Yichang Humanwell Pharmaceutical Co., Ltd., China | INDUSTRY |
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This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: Remimazolam Besylate | Experimental | Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of Remimazolam is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.2-1 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and Remimazolam, no analgesic or sedative could be used during the experimental time period. |
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| Positive control group: Propofol | Active Comparator | Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of propofol is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.3-4.0 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and propofol, no analgesic or sedative could be used during the experimental time period. Rescue therapy for experimental group During the treatment of the experimental group, if the RASS cannot be maintained at 0 to -2 points at the maximum Remimazolam maintenance dose of 1 mg/kg/h, a loading dose of propofol (0.2 mg/kg) can be given intravenously. If RASS fails to satisfied after three loading doses of propofol, Remimazolam is discarded and 0.3-4.0 mg/kg/h of propofol are used as rescue therapy for experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Besylate | Drug | Remimazolam Besylate are used as sedatives for subjects in this arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction rate of sedation | (number of subjects that meets satisfied RASS score under prescribed dose of sedative agents during study / total number of subjects) ×100% | 24 hours since injection of sedatives |
| Rate of major clinical events | (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. | 48 hours since injection of sedatives |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of delirium | (subjects with delirium / total number of subjects ×100%) by 12h and 24h after entering ICU | 48 hours since injection of sedatives |
| Time to weaning and extubation | Time to weaning and extubation |
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Inclusion criteria
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Longxiang Su, M.D. | Contact | +8615652797257 | slx77@163.com | |
| Shengjun Liu, M.D. | Contact | +8618911952413 | liushengjun100@126.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34805204 | Derived | 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. |
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So far, we haven't decide if individual participant data are suitable to share with other researchers.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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This is a open label clinical trial.
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| Propofol | Drug | Propofol are used as sedatives for subjects in this arm. |
|
| 48 hours since injection of sedatives |
| Difficulty of nursing | By Barthel index assessment | 48 hours since injection of sedatives |
| 28-days survival | (number of subjects that alive in 28-days since ICU entry/ total number of subjects) ×100% | 28 days since injection of sedatives |
| incidence of rescue therapy in experimental group | (number of subjects that receive rescue therapy in experimental group/ total number of subjects) ×100% | 24 hours since injection of sedatives |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |