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

Phase 4

Completed

• Conditions: Ischemia-Reperfusion Injury
• Interventions: Drug: Placebo; Drug: dexmedetomidine

• Registration Number: NCT05598177
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-28
• Primary Completion: 2023-05-30
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group R	Placebo	The participant will use saline of the same volume as dexmedetomidine as a placebo during anesthesia.
Group D	dexmedetomidine	The participant will be infused with dexmedetomidine during anesthesia to protect the myocardium.

Primary Outcome Measures

Name	Time	Method
troponin T level	72 hours after operation	the level of troponin in the participant's serum

Secondary Outcome Measures

Name	Time	Method
AQP4、iNOS andTNF-α level	the end of the operation	the level of AQP4、iNOS andTNF-α in the participant's serum

Trial Locations

Locations (1)

Affiliated Hospital Nantong University; 🇨🇳 Nantong, Jiangsu, China