Remimazolam Besylate in Sedation of Postcardioperative Patients

Not Applicable

Recruiting

• Conditions: Remimazolam; Propofol; Sedation; Mechanical Ventilation; Intensive Care; Cardiac Surgery
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT06716840
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-29
• Study First Posted: 2024-12-04
• Study Start: 2025-02-10
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group	Remimazolam	-
propofol group	Propofol	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
changes in heart rate	up to 2 days	dynamic changes of heart rate were recorded during sedation
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
28-day mortality	From enrollment to the end of treatment at 28 days	28-day mortality after enrollment

Trial Locations

Locations (1)

First afflilated hospital of zhejiang university school of medicine; 🇨🇳 Hangzhou, Zhejiang, China