Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion Injury in Patients Undergoing Open Heart Surgery With Cardiopulmonary Bypass

NCT ID: NCT05598177

Last Updated: 2024-03-21

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

About 200000 cardiac operations are performed in China every year. Cardiopulmonary bypass is the basic strategy of open-heart surgery, which may lead to myocardial ischemia-reperfusion injury and low cardiac output syndrome. It will inevitably affect the patient's postoperative recovery. A number of studies have shown that dexmedetomidine, as an auxiliary sedative, has the effects of inhibiting stress response, antiarrhythmia and cardiac protection.Dexmedetomidine has been widely used in anesthesia in cardiac surgery. However, at present, few clinical studies pay attention to its mechanism. In this study, dexmedetomidine will be used in cardiac surgery with cardiopulmonary bypass to explore the mechanism of cardiac ischemia-reperfusion injury and the protective effect of dexmedetomidine.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemia-Reperfusion Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group D

The participant will be infused with dexmedetomidine during anesthesia to protect the myocardium.

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

The participant will pump dexmedetomidine at the rate of 1μg/(Kg·h) for 10 minutes at the beginning of anesthesia induction, and then maintain the pump at a rate of 0.5μg/(Kg·h) during the operation.

Group R

The participant will use saline of the same volume as dexmedetomidine as a placebo during anesthesia.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The participant will pump saline without dexmedetomidine at the same speed as group D.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dexmedetomidine

The participant will pump dexmedetomidine at the rate of 1μg/(Kg·h) for 10 minutes at the beginning of anesthesia induction, and then maintain the pump at a rate of 0.5μg/(Kg·h) during the operation.

Intervention Type DRUG

Placebo

The participant will pump saline without dexmedetomidine at the same speed as group D.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18-70 years
2. American Society of Anesthesiologists(ASA) physical status of I-Ⅳ
3. BMI: 18.5-28 kg/m2
4. Type of operation: elective open-heart surgery with cardiopulmonary bypass
5. The patient and/or family members have signed the informed consent.

Exclusion Criteria

1. Preoperative diagnosis of heart failure 、gradeⅡ-Ⅲ heart block and diabetes
2. LEVF\<40%
3. Severe coagulation dysfunction
4. Severe heart, lung, liver and kidney insufficiency
5. Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases
6. Perioperative allogeneic blood transfusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yibin Qin

associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yibin Qin

Role: STUDY_DIRECTOR

Affiliated Hospital of Nantong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Affiliated Hospital Nantong University

Nantong, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-K125

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.