Cardiac Surgery, Intensive Care, Mechanical Ventilation, Propofol, Remimazolam, Sedation
Conditions
Brief summary
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.
Interventions
DRUGRemimazolam
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.
DRUGPropofol
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.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years ; 2. admitted to the intensive care unit after cardiac surgery with techanical ventilation； 3. expected to extubation within 48hours ； 4. participant has given informed consent
Exclusion criteria
1. pregnant or lactating women 2. known or suspected hypersensitivity to the study drug 3. history of impaired consciousness or psychiatric illness 4. severe bradycardia with a heart rate of \< 50 beats per minute 5. systolic blood pressure \< 90 mmHg with fluid resuscitation and vasopressor maintenance 6. atrioventricular block（II or III degree）, Left ventricular ejection fraction(LVEF) \<30% 7. participated in other clinical studies within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of time in the target sedation range | up to 2 days | The primary outcome was the percentage of time in the target sedation range without rescue sedation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ventilator-free days | From enrollment to 7 days | ventilator-free days at day 7 |
| the score of confusion assessment method for the intensive care unit ( CAM-ICU) | From enrollment to the end of treatment at 28 days | diagnose the delirium by the CAM-ICU score，and calculate the incidence of delirium |
| stay length | From enrollment to the end of treatment at 28 days | length of intensive care unit stay and hospital stay |
| changes in heart rate | up to 2 days | dynamic changes of heart rate were recorded during sedation |
| extubation time | up to 2 days | from stopping sedative medication to removing the endotracheal tube |
| extubation success rate | up to 4 days | no re-intubation within 48 hours after extubation |
| changes in blood pressure | up to 2 days | dynamic changes of blood pressure were recorded during sedation |
| 28-day mortality | From enrollment to the end of treatment at 28 days | 28-day mortality after enrollment |
Countries
China
Contacts
Primary ContactYu Wenqiao PhD
Outcome results
None listed