Remimazolam Besylate in Sedation of Postcardioperative Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years ;
admitted to the intensive care unit after cardiac surgery with techanical ventilation；
expected to extubation within 48hours ；
participant has given informed consent
Disqualifiers
pregnant or lactating women
known or suspected hypersensitivity to the study drug
history of impaired consciousness or psychiatric illness
severe bradycardia with a heart rate of < 50 beats per minute
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
Drugparticipants 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.
Propofol
Drugparticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Remimazolam groupExperimental treatment 1 intervention
Group B: propofol groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
percentage of time in the target sedation range
The primary outcome was the percentage of time in the target sedation range without rescue sedation.
Time frame
up to 2 daysSecondary outcomes
1
extubation time
from stopping sedative medication to removing the endotracheal tube
Time frame
up to 2 days2
extubation success rate
no re-intubation within 48 hours after extubation
Time frame
up to 4 days3
changes in blood pressure
dynamic changes of blood pressure were recorded during sedation
Time frame
up to 2 days4
changes in heart rate
dynamic changes of heart rate were recorded during sedation
Time frame
up to 2 daysSponsors and contacts
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Source ClinicalTrials.gov