Amobarbital and Cardiopulmonary Bypass

NCT06757868 | Recruiting

• 1 other identifier: AMOC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Cardiac recurrence time

  Stop extracorporeal circulation until heart beat time

  1 hour after heart beat recurrence

Secondary Outcomes (2)

• extubation time

  1day

• cTnI

  2 days

Study Arms (2)

Amo group

EXPERIMENTAL

amobarbital 1mg/kg is given prior to cardiopulmonary bypass

Drug: Amobarbital

Mida group

ACTIVE COMPARATOR

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Drug: Midazolam

Interventions

Amobarbital DRUG

Amobarbital 1mg/kg is given prior to cardiopulmonary bypass

Also known as: AMO

Amo group

Midazolam DRUG

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

Also known as: MIDA

Mida group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Amobarbital; Midazolam

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Aihua Du, Dr

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

mujun chang, Dr

CONTACT

+862783663625; changmujun@hotmail.com

Pu zhou, Dr

CONTACT

+862783663625; tongjihlunli@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)