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

NCT05598177 | Completed Phase 4

• 1 other identifier: 2022-K125
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia-Reperfusion Injury

Outcome Measures

Primary Outcomes (5)

• troponin T level

  the level of troponin in the participant's serum

  before operation

• troponin T level

  the level of troponin in the participant's serum

  the end of operation

• troponin T level

  the level of troponin in the participant's serum

  when the participant returned to the ward after the operation

• troponin T level

  the level of troponin in the participant's serum

  24 hours after operation

• troponin T level

  the level of troponin in the participant's serum

  72 hours after operation

Secondary Outcomes (5)

• AQP4、iNOS andTNF-α level

  before operation

• AQP4、iNOS andTNF-α level

  when blocking the ascending aorta

• AQP4、iNOS andTNF-α level

  when developing the ascending aorta

• AQP4、iNOS andTNF-α level

  when cardiopulmonary bypass is stopped

• AQP4、iNOS andTNF-α level

  the end of the operation

Study Arms (2)

Group D

EXPERIMENTAL

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

Drug: dexmedetomidine

Group R

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Group D

Placebo DRUG

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

Group R

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital Nantong University

Nantong, Jiangsu, 226000, China

Location

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yibin Qin

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: September 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)