Amobarbital and Cardiopulmonary Bypass

March 18, 2025 updated by: aijun xu, Tongji Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amo group
amobarbital 1mg/kg is given prior to cardiopulmonary bypass
Drug: Amobarbital
Amobarbital 1mg/kg is given prior to cardiopulmonary bypass
Other Names:
  • AMO
Active Comparator: Mida group
midazolam 0.1mg/kg is given prior to cardiopulmonary bypass
Drug: Midazolam
midazolam 0.1mg/kg is given prior to cardiopulmonary bypass
Other Names:
  • MIDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac recurrence time
Time Frame: 1 hour after heart beat recurrence
Stop extracorporeal circulation until heart beat time
1 hour after heart beat recurrence

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cTnI
Time Frame: 2 days
Using enzyme-linked immunosorbent assay (ELISA) to detect serum cardiac troponin I (cTnI) in patients
2 days
extubation time
Time Frame: 1day
time from stopping anesthetics to extubation
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Chair: Aihua Du, Dr, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

December 26, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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