Cardiopulmonary BypassNCT06757868
Amobarbital and Cardiopulmonary Bypass
A study testing Amobarbital and Midazolam in people with Cardiopulmonary Bypass, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Amobarbital and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Amobarbital, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmobarbitalDrug
Also called AMO
Amobarbital 1mg/kg is given prior to cardiopulmonary bypass
MidazolamDrug
Also called MIDA
midazolam 0.1mg/kg is given prior to cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Amo group | Experimental | amobarbital 1mg/kg is given prior to cardiopulmonary bypass Receives: Drug: Amobarbital |
| Mida group | Active comparator | midazolam 0.1mg/kg is given prior to cardiopulmonary bypass Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac recurrence time
Stop extracorporeal circulation until heart beat time
Measured: 1 hour after heart beat recurrence
Secondary outcomes (2)
extubation time
time from stopping anesthetics to extubation
Measured: 1day
cTnI
Using enzyme-linked immunosorbent assay (ELISA) to detect serum cardiac troponin I (cTnI) in patients
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Aihua Du, Dr, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757868
- Sponsor's protocol ID
- AMOC
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Amobarbital on Myocardial Protection and Prognosis in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06757868
- Acronym / sponsor ID
- AMOC
- Conditions
- Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amo group | Experimental | Drug: Amobarbitalamobarbital 1mg/kg is given prior to cardiopulmonary bypass |
| Mida group | Active comparator | Drug: Midazolammidazolam 0.1mg/kg is given prior to cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmobarbitalAlso: AMOAmobarbital 1mg/kg is given prior to cardiopulmonary bypass | Drug | Amo group |
| MidazolamAlso: MIDAmidazolam 0.1mg/kg is given prior to cardiopulmonary bypass | Drug | Mida group |
Primary outcome
Cardiac recurrence time
Time frame: 1 hour after heart beat recurrence
Stop extracorporeal circulation until heart beat time
2 secondary outcomes
extubation time
Time frame: 1day
cTnI
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Bypass
RecruitingObservational study
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Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
Cardiopulmonary Bypass, Obese Patients
Not yet recruitingPhase 3
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
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A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Cardiac Surgery-associated Acute Kidney Injury
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aihua Du, Dr study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amobarbital and Midazolam in people with Cardiopulmonary Bypass, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac recurrence time (time frame: 1 hour after heart beat recurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.