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

Primary Purpose

Ischemia-Reperfusion Injury

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
dexmedetomidine
Placebo
Sponsored by
Affiliated Hospital of Nantong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemia-Reperfusion Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital Nantong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group D

Group R

Arm Description

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

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

Outcomes

Primary Outcome Measures

troponin T level
the level of troponin in the participant's serum
troponin T level
the level of troponin in the participant's serum
troponin T level
the level of troponin in the participant's serum
troponin T level
the level of troponin in the participant's serum
troponin T level
the level of troponin in the participant's serum

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2022
Last Updated
October 27, 2022
Sponsor
Affiliated Hospital of Nantong University
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1. Study Identification

Unique Protocol Identification Number
NCT05598177
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Nantong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia-Reperfusion Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group D
Arm Type
Experimental
Arm Description
The participant will be infused with dexmedetomidine during anesthesia to protect the myocardium.
Arm Title
Group R
Arm Type
Placebo Comparator
Arm Description
The participant will use saline of the same volume as dexmedetomidine as a placebo during anesthesia.
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The participant will pump saline without dexmedetomidine at the same speed as group D.
Primary Outcome Measure Information:
Title
troponin T level
Description
the level of troponin in the participant's serum
Time Frame
before operation
Title
troponin T level
Description
the level of troponin in the participant's serum
Time Frame
the end of operation
Title
troponin T level
Description
the level of troponin in the participant's serum
Time Frame
when the participant returned to the ward after the operation
Title
troponin T level
Description
the level of troponin in the participant's serum
Time Frame
24 hours after operation
Title
troponin T level
Description
the level of troponin in the participant's serum
Time Frame
72 hours after operation
Secondary Outcome Measure Information:
Title
AQP4、iNOS andTNF-α level
Description
the level of AQP4、iNOS andTNF-α in the participant's serum
Time Frame
before operation
Title
AQP4、iNOS andTNF-α level
Description
the level of AQP4、iNOS andTNF-α in the participant's serum
Time Frame
when blocking the ascending aorta
Title
AQP4、iNOS andTNF-α level
Description
the level of AQP4、iNOS andTNF-α in the participant's serum
Time Frame
when developing the ascending aorta
Title
AQP4、iNOS andTNF-α level
Description
the level of AQP4、iNOS andTNF-α in the participant's serum
Time Frame
when cardiopulmonary bypass is stopped
Title
AQP4、iNOS andTNF-α level
Description
the level of AQP4、iNOS andTNF-α in the participant's serum
Time Frame
the end of the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yibin Qin
Phone
13815212600
Email
572537172@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengzhen Huang
Phone
19555001169
Email
944451483@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yibin Qin
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Hospital Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhang
Phone
0513-85052390

12. IPD Sharing Statement

Learn more about this trial

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

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