Clinical trial NCT06716840: Remimazolam Besylate in Sedation of Postcardioperative Patients
Official title: Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Remimazolam
Propofol
Sedation
Mechanical Ventilation
Intensive Care
Cardiac Surgery
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: percentage of time in the target sedation range
timeFrame: up to 2 days
Secondary outcomes:
measure: extubation time
timeFrame: up to 2 days
measure: extubation success rate
timeFrame: up to 4 days
measure: changes in blood pressure
timeFrame: up to 2 days
measure: changes in heart rate
timeFrame: up to 2 days
measure: ventilator-free days
timeFrame: From enrollment to 7 days
measure: the score of confusion assessment method for the intensive care unit ( CAM-ICU)
timeFrame: From enrollment to the end of treatment at 28 days
measure: stay length
timeFrame: From enrollment to the end of treatment at 28 days
measure: 28-day mortality
timeFrame: From enrollment to the end of treatment at 28 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First afflilated hospital of zhejiang university school of medicine
state: Zhejiang
Study officials:
References: