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

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05598177
Collaborator
(none)
64
1
2
19
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion : a Randomized, Double-blind Clinical Trial
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group D

The participant will be infused with dexmedetomidine during anesthesia to protect the myocardium.

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 Comparator: Group R

The participant will use saline of the same volume as dexmedetomidine as a placebo during anesthesia.

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

Outcome Measures

Primary Outcome Measures

  1. troponin T level [before operation]

    the level of troponin in the participant's serum

  2. troponin T level [the end of operation]

    the level of troponin in the participant's serum

  3. troponin T level [when the participant returned to the ward after the operation]

    the level of troponin in the participant's serum

  4. troponin T level [24 hours after operation]

    the level of troponin in the participant's serum

  5. troponin T level [72 hours after operation]

    the level of troponin in the participant's serum

Secondary Outcome Measures

  1. AQP4、iNOS andTNF-α level [before operation]

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

  2. AQP4、iNOS andTNF-α level [when blocking the ascending aorta]

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

  3. AQP4、iNOS andTNF-α level [when developing the ascending aorta]

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

  4. AQP4、iNOS andTNF-α level [when cardiopulmonary bypass is stopped]

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

  5. AQP4、iNOS andTNF-α level [the end of the operation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital Nantong University Nantong Jiangsu China 226000

Sponsors and Collaborators

  • Affiliated Hospital of Nantong University

Investigators

  • Study Director: Yibin Qin, Affiliated Hospital of Nantong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yibin Qin, associate chief physician, Affiliated Hospital of Nantong University
ClinicalTrials.gov Identifier:
NCT05598177
Other Study ID Numbers:
  • 2022-K125
First Posted:
Oct 28, 2022
Last Update Posted:
Oct 28, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2022