Effect of Stellate Ganglion Block on Cardiac and Renal Function After Cardiopulmonary Bypass Cardiac Surgery

Study Overview
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Brief Summary
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The incidence of acute kidney injury after cardiopulmonary bypass cardiac surgery is high, which increases postoperative mortality and is not conducive to the prognosis of patients. Stellate ganglion blocks increase renal blood flow, reduce inflammation and stress, and protect the heart muscle. In this study, stellate ganglion block was used to promote rapid recovery of heart and kidney function after cardiopulmonary bypass cardiac surgery.

Official Title
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Effect of Stellate Ganglion Block on Cardiac and Renal Function After Cardiopulmonary Bypass Cardiac Surgery

Conditions
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Stellate Ganglion Block

Intervention / Treatment
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* Drug: Stellate ganglion block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 100 patients with elective first cardiac surgery, aged 40-80 years, who agreed to participate in the trial and signed an informed consent form. Patients with diabetes mellitus, if any, were regularly treated and had preoperative fasting glucose ≤180 mg/dL (10 mmol/L). No consciousness or speech impairment and able to cooperate with neurological physical examinations, cognitive function tests and other neurological functional assessments. No preoperative neurocognitive impairment, Mini Mental State Examination (MMSE) score: illiterate ≥ 17, primary school ≥ 20, secondary school and above ≥ 24, and Montreal Cognitive Assessment (MoCA) score ≥ 26. 26 points. No preoperative anxiety or depression, with a Hamilton Anxiety Scale (HAMA) score ≤ 7 and a Hamilton Depression Scale (HAMD) score ≤ 7. Pre-operative neurological physical examination National Institute of Health Stroke Scale (NIHSS) score ≤ 4, no new intracranial infarction, bleeding, tumour, inflammation, etc. within 3 months prior to surgery. Correction of anemia, hypoproteinemia and other nutritional status prior to surgery. Exclusion Criteria: Emergency cardiac surgery. Non-CPB cardiac surgery. Severe heart failure with left ventricular ejection fraction <30%. Contraindications to TEE. Renal disease requiring replacement therapy. Combined multi-organ insufficiency. Severe infection requiring continuous antibiotic therapy. Significant application of hormonal or non-steroidal anti-inflammatory agents within the last 2 weeks. Neurological or psychiatric diagnoses that could affect neurocognitive performance or neurocognitive testing, such as severe traumatic brain injury or substance abuse. Prior neurodegenerative or psychiatric disorders. Severe audiovisual impairment and inability to communicate.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate ganglion block<br> | Drug: Stellate ganglion block<br>* Before anesthesia induction, ultrasound-guided stellate ganglion block is performed, injecting 7 ml of 0.375% ropivacaine.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in renal blood flow | Renal blood flow indicators | 30 minutes after the start of the operation , 30 minutes after the start of cardiopulmonary , 30 minutes after the end of cardiopulmonary bypassbypass | 
| Indicators of kidney function | Cystatin C, | 1 day before surgery, 1 hour after the end of the operation, 1 day after the end of the operation, 3 day after the end of the operation, 7 day after the end of the operation | 
| Changes in left ventricular systolic function | EDV, ESV, EF are assessed by TEE | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | 
| Changes in right ventricular systolic function | Right ventricular systolic function changes, such as TAPSE, are assessed by TEE | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | 
| Changes in right ventricular diastolic function | Right ventricular diastolic function changes | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | 
| Changes in blood flow in the coronary sinuse | TEE assessment of coronary sinus flow changes, such as maximum systolic flow, | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | 
| Changes in myocardial performance index | ET, IVCT, IVRT are measured by TEE to calculate the myocardial performance index | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | 
| Changes in cerebral blood flow | Cerebral flow tests are performed by TCD, such as systolic peak flow velocity (Vs), | The day before surgery , 30 min after the start of extracorporeal bypass , 30 minutes after the end of extracorporeal bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the level of Cardiac output | The above results should be measured immediately after induction, at the beginning | into ICU 30 minutes | 
| Changes in the level of SVR | The above results should be measured immediately after induction, at the beginning | into ICU 30 minutes | 
| Changes in the level of SVRI | The above results should be measured immediately after induction, at the beginning | into ICU 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stellate ganglion block, Postoperative acute kidney injury, Renal blood flow