Amobarbital and Cardiopulmonary Bypass

Not Applicable

Recruiting

• Conditions: Cardiopulmonary Bypass
• Interventions: Drug: Amobarbital; Drug: Midazolam

• Registration Number: NCT06757868
• Lead Sponsor: Tongji Hospital

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 Timeline

• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Study First Posted: 2025-01-03
• Study Start: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amo group	Amobarbital	amobarbital 1mg/kg is given prior to cardiopulmonary bypass
Mida group	Midazolam	midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Cardiac recurrence time	1 hour after heart beat recurrence	Stop extracorporeal circulation until heart beat time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji hospital; 🇨🇳 Wuhan, Hubei, China