Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06757868

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day

Participants receive either amobarbital or midazolam prior to cardiopulmonary bypass during elective cardiac surgery.

1 visit (in-person, surgery day)

Follow-up

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

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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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