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

Ischemia-Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05598177
• Other study ID #: 2022-K125
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Affiliated Hospital of Nantong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged 18-70 years

2. American Society of Anesthesiologists(ASA) physical status of I-?

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 ?grade?-? 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Ischemia-Reperfusion Injury
• Myocardial Ischemia
• Reperfusion Injury

Intervention

Drug:
• 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.
• Placebo
The participant will pump saline without dexmedetomidine at the same speed as group D.

Locations

Country	Name	City	State
China	Affiliated Hospital Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	troponin T level	the level of troponin in the participant's serum	before operation
Primary	troponin T level	the level of troponin in the participant's serum	the end of operation
Primary	troponin T level	the level of troponin in the participant's serum	when the participant returned to the ward after the operation
Primary	troponin T level	the level of troponin in the participant's serum	24 hours after operation
Primary	troponin T level	the level of troponin in the participant's serum	72 hours after operation
Secondary	AQP4?iNOS andTNF-a level	the level of AQP4?iNOS andTNF-a in the participant's serum	before operation
Secondary	AQP4?iNOS andTNF-a level	the level of AQP4?iNOS andTNF-a in the participant's serum	when blocking the ascending aorta
Secondary	AQP4?iNOS andTNF-a level	the level of AQP4?iNOS andTNF-a in the participant's serum	when developing the ascending aorta
Secondary	AQP4?iNOS andTNF-a level	the level of AQP4?iNOS andTNF-a in the participant's serum	when cardiopulmonary bypass is stopped
Secondary	AQP4?iNOS andTNF-a level	the level of AQP4?iNOS andTNF-a in the participant's serum	the end of the operation