Using Remimazolam for Sedation in Patients After Heart Surgery
Remimazolam Besylate Versus Propofolfor Sedation of Postcardioperative Patients in Intensive Care Unit: a Prospective,Single-center,Randomized Non-inferior Trial
This study tests if a new sedative called remimazolam can help heart surgery patients recover better and get off breathing machines faster compared to a standard sedative.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06716840 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of remimazolam besylate as a sedative for patients recovering from cardiac surgery who require mechanical ventilation. Participants aged 18 and older will be randomly assigned to receive either remimazolam or propofol for sedation, with the goal of achieving effective sedation while minimizing adverse effects and facilitating quicker extubation. The study aims to determine if remimazolam can provide a safer and more efficient sedation option compared to traditional sedatives.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have undergone cardiac surgery and require mechanical ventilation within 48 hours post-operation.
Not a fit: Patients who are pregnant, have certain cardiac conditions, or have a history of psychiatric illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices in intensive care, enhancing recovery times for patients after cardiac surgery.
How similar studies have performed: While the use of remimazolam is relatively novel in this context, other studies have shown promising results with similar sedative approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- First afflilated hospital of zhejiang university school of medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yu Wenqiao PhD
- Email: yuwenqiao1980@zju.edu.cn
- Phone: +86-18868787588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.