First afflilated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
NCT Number: NCT06716840
Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation,in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally,the investigators will compare the sedation effect and safety between the 2 groups ,to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
participants in the remimazolam group received remimazolam besylate intravenously at an initial infusion rate of 0.2mg/kg/h and adjusted (maximum of 2 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale(RASS) score between - 2 and 0.If the maximum dose of remimazolam was insufficient to sedate, add rescue dexmedetomidine.
participants in the propofol group received propofol intravenously at an initial infusion rate of 1 mg/kg/h and adjusted (maximum of 4 mg/kg/h) to maintain a Richmond Agitation-Sedation Scale (RASS) score between - 2 and 0.If the maximum dose of propofol was insufficient to sedate, add rescue dexmedetomidine.
Time frame: up to 2 days
The primary outcome was the percentage of time in the target sedation range without rescue sedation.
Time frame: up to 2 days
from stopping sedative medication to removing the endotracheal tube
Time frame: up to 4 days
no re-intubation within 48 hours after extubation
Time frame: up to 2 days
dynamic changes of blood pressure were recorded during sedation
Time frame: up to 2 days
dynamic changes of heart rate were recorded during sedation
Time frame: From enrollment to 7 days
ventilator-free days at day 7
Time frame: From enrollment to the end of treatment at 28 days
diagnose the delirium by the CAM-ICU score,and calculate the incidence of delirium
Time frame: From enrollment to the end of treatment at 28 days
length of intensive care unit stay and hospital stay
Time frame: From enrollment to the end of treatment at 28 days
28-day mortality after enrollment
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Zhejiang University
Other
Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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