Clinical trial NCT05598177: Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion Injury in Patients Undergoing Open Heart Surgery With Cardiopulmonary Bypass
Official title: Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion : a Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemia-Reperfusion Injury
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: troponin T level
timeFrame: before operation
measure: troponin T level
timeFrame: the end of operation
measure: troponin T level
timeFrame: when the participant returned to the ward after the operation
measure: troponin T level
timeFrame: 24 hours after operation
measure: troponin T level
timeFrame: 72 hours after operation
Secondary outcomes:
measure: AQP4、iNOS andTNF-α level
timeFrame: before operation
measure: AQP4、iNOS andTNF-α level
timeFrame: when blocking the ascending aorta
measure: AQP4、iNOS andTNF-α level
timeFrame: when developing the ascending aorta
measure: AQP4、iNOS andTNF-α level
timeFrame: when cardiopulmonary bypass is stopped
measure: AQP4、iNOS andTNF-α level
timeFrame: the end of the operation
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Yibin Qin
role: STUDY_DIRECTOR
References: