NCT06496165Not yet recruiting
Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients
Comparison of the Effects of Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients：a Prospective, Single Blinded, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 338 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 15 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06496165
What you commit to
- Study type: Interventional
- Planned participants: 338
- From 15 Jul 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- delirium before surgery
- severe cognitive dysfunction before surgery
- patients who are still not awake 12 hours after surgery
- patients with much drainage, the surgery ask for blood pressure control or reopen the chest
Other illness
- patients who are allergy to propofol or remimazolam
Other
- patients with over degree II A-V block or consistent bradycardia
- patients who are agitated or cannot follow command
- patients with mechanical circulatory support (ECMO, IABP)
- BMI≥30kg/m2
Who the study is looking for
- Sign the informed consent form voluntarily and follow the plan requirements;
- age over 60 years old;
- post coronary artery bypass surgery;
- anticipated mechanical ventilation duration \>8 hours
- admission to the cardiac surgery intensive care unit of Zhongshan hospital, Fudan University
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.