Actively Recruiting
The Effect of Amobarbital on Myocardial Protection and Prognosis in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Led by Tongji Hospital · Updated on 2025-03-21
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore how amobarbital affects heart muscle protection and patient outcomes during cardiac surgery involving cardiopulmonary bypass. The study investigates a new use for an older drug, seeking to provide a solid scientific foundation for its potential role in improving clinical treatment for patients undergoing this type of surgery. Participants are randomly assigned to one of two groups: one group receives amobarbital at a dose of 1 mg/kg before the cardiopulmonary bypass, and the other group receives midazolam at 0.1 mg/kg before the same procedure. The study uses a double-blind design to monitor and compare the effects of these treatments on heart function during surgery. During the trial, researchers will assess how quickly the heart recovers after bypass by measuring cardiac recurrence time within one hour after heartbeat returns. They will also track secondary outcomes such as extubation time one day after surgery and cardiac troponin I levels two days post-surgery. Participants will be closely monitored throughout the surgical and recovery periods to evaluate the treatments' impact on heart protection and overall prognosis.
CONDITIONS
Brief Title
Amobarbital and Cardiopulmonary Bypass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age range: 18 to 65 years old
- Undergoing elective cardiac surgery with extracorporeal circulation
- ASA physical status II or III
- Surgery duration between 3 and 6 hours
- Signed informed consent form
You will not qualify if you...
- Body mass index less than 18 kg/m2 or greater than 30 kg/m2
- History or potential history of drug abuse or alcohol dependence
- Preoperative use of sedatives or analgesics
- Severe liver or kidney dysfunction
- Allergy or potential allergy to barbiturates
- Coagulation dysfunction, endocrine disorders, or other conditions affecting hemodynamic status
- Participation in other clinical studies within the past 3 months
- Any other condition deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive either amobarbital or midazolam prior to cardiopulmonary bypass during elective cardiac surgery.
1 visit (in-person, surgery day)
Duration - 2 days
Participants are monitored after surgery to assess cardiac function and recovery.
2 visits (1 day and 2 days post-surgery)
Trial Site Locations
Total: 1 location
1
Tongji hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
M
mujun chang, Dr
P
Pu zhou, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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