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OpenTrials
Completed

NCT Number: NCT06757868

Amobarbital and Cardiopulmonary Bypass

Explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji hospital

Wuhan, Hubei, 430030, China

About this study

AMO is a short acting complex I blocker that blocks mitochondrial complex I between flavoprotein and ubiquitin, and its blocking effect can be rapidly reversed. Our study is to explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range: 18-65 years old, undergo elective cardiac surgery with extracorporeal circulation.
  • ASA II-III;
  • surgical duration is 3-6 hours;
  • Sign the informed consent form

Exclusion criteria

  • BMI less than 18 kg/m2 or greater than 30 kg/m2;
  • Individuals with a history or potential history of drug abuse or alcohol dependence;
  • Preoperative use of sedatives or analgesics;
  • Individuals with severe liver and kidney dysfunction;
  • Individuals who are allergic or potentially allergic to barbiturates;
  • Patients with coagulation dysfunction, endocrine disorders, or other conditions that affect hemodynamic status;
  • Participated in other clinical studies in the past 3 months;
  • The researchers believe that participants who are not suitable to participate in this study.

Treatment and study plan

Amobarbital

Drug

Amobarbital 1mg/kg is given prior to cardiopulmonary bypass

Other names: AMO

midazolam

Drug

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Other names: MIDA

Primary outcomes

  1. Cardiac recurrence time

    Time frame: 1 hour after heart beat recurrence

    Stop extracorporeal circulation until heart beat time

Secondary outcomes

  1. extubation time

    Time frame: 1day

    time from stopping anesthetics to extubation

  2. cTnI

    Time frame: 2 days

    Using enzyme-linked immunosorbent assay (ELISA) to detect serum cardiac troponin I (cTnI) in patients

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

The Effect of Amobarbital on Myocardial Protection and Prognosis in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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