The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients
NCT ID: NCT04947345
Last Updated: 2021-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
84 participants
INTERVENTIONAL
2021-09-01
2022-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group: Remimazolam Besylate
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.
Remimazolam Besylate
Remimazolam Besylate are used as sedatives for subjects in this arm.
Positive control group: Propofol
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.
Propofol
Propofol are used as sedatives for subjects in this arm.
Interventions
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Remimazolam Besylate
Remimazolam Besylate are used as sedatives for subjects in this arm.
Propofol
Propofol are used as sedatives for subjects in this arm.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Yichang Humanwell Pharmaceutical Co., Ltd., China
INDUSTRY
Peking Union Medical College Hospital
OTHER
Responsible Party
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Central Contacts
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References
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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.
Other Identifiers
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20-JS-2814
Identifier Type: -
Identifier Source: org_study_id
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