Amobarbital and Cardiopulmonary Bypass

NCT ID: NCT06757868

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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

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Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Amo group

amobarbital 1mg/kg is given prior to cardiopulmonary bypass

Group Type EXPERIMENTAL

Amobarbital

Intervention Type DRUG

Amobarbital 1mg/kg is given prior to cardiopulmonary bypass

Mida group

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Interventions

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Amobarbital

Amobarbital 1mg/kg is given prior to cardiopulmonary bypass

Intervention Type DRUG

Midazolam

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Intervention Type DRUG

Other Intervention Names

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AMO MIDA

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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aijun xu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aihua Du, Dr

Role: STUDY_CHAIR

Tongji Hospital

Locations

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Tongji hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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mujun chang, Dr

Role: CONTACT

+862783663625

Pu zhou, Dr

Role: CONTACT

+862783663625

Facility Contacts

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aijun Xu, Dr.

Role: primary

86-27-83663173

aihua Du, Dr.

Role: backup

02783663625

Other Identifiers

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AMOC

Identifier Type: -

Identifier Source: org_study_id

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