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Clinical Trials/NCT06757868
NCT06757868CompletedNot Applicable

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

Tongji Hospital1 site in 1 country80 target enrollmentStarted: February 1, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Cardiac recurrence time

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Amo group

Experimental

amobarbital 1mg/kg is given prior to cardiopulmonary bypass

Intervention: Amobarbital (Drug)

Mida group

Active Comparator

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Intervention: Midazolam (Drug)

Outcomes

Primary Outcomes

Cardiac recurrence time

Time Frame: 1 hour after heart beat recurrence

Stop extracorporeal circulation until heart beat time

Secondary Outcomes

  • extubation time(1day)
  • cTnI(2 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

aijun xu

Doctor

Tongji Hospital

Study Sites (1)

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