Skip to main content
OpenTrials
Completed

NCT Number: NCT05598177

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemia-Reperfusion Injury Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Affiliated Hospital Nantong University

Nantong, Jiangsu, 226000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Preoperative diagnosis of heart failure 、gradeⅡ-Ⅲ heart block and diabetes
  • LEVF<40%
  • Severe coagulation dysfunction
  • Severe heart, lung, liver and kidney insufficiency
  • Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases
  • Perioperative allogeneic blood transfusion

Treatment and study plan

Dexmedetomidine

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.

Placebo

Drug

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

Primary outcomes

  1. troponin T level

    Time frame: before operation

    the level of troponin in the participant's serum

  2. troponin T level

    Time frame: the end of operation

    the level of troponin in the participant's serum

  3. troponin T level

    Time frame: when the participant returned to the ward after the operation

    the level of troponin in the participant's serum

  4. troponin T level

    Time frame: 24 hours after operation

    the level of troponin in the participant's serum

  5. troponin T level

    Time frame: 72 hours after operation

    the level of troponin in the participant's serum

Secondary outcomes

  1. AQP4、iNOS andTNF-α level

    Time frame: before operation

    the level of AQP4、iNOS andTNF-α in the participant's serum

  2. AQP4、iNOS andTNF-α level

    Time frame: when blocking the ascending aorta

    the level of AQP4、iNOS andTNF-α in the participant's serum

  3. AQP4、iNOS andTNF-α level

    Time frame: when developing the ascending aorta

    the level of AQP4、iNOS andTNF-α in the participant's serum

  4. AQP4、iNOS andTNF-α level

    Time frame: when cardiopulmonary bypass is stopped

    the level of AQP4、iNOS andTNF-α in the participant's serum

  5. AQP4、iNOS andTNF-α level

    Time frame: the end of the operation

    the level of AQP4、iNOS andTNF-α in the participant's serum

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2022
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.