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

Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion : a Randomized, Double-blind Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05598177
Enrollment
64
Registered
2022-10-28
Start date
2022-09-01
Completion date
2023-12-31
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia-Reperfusion Injury

Brief summary

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.

Interventions

DRUGdexmedetomidine

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.

DRUGPlacebo

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

Sponsors

Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
troponin T levelbefore operationthe level of troponin in the participant's serum

Secondary

MeasureTime frameDescription
AQP4、iNOS andTNF-α levelbefore operationthe level of AQP4、iNOS andTNF-α in the participant's serum

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026