SGB Reduces the Incidence and Severity of CSA-AKI

NCT ID: NCT05652179

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2023-12-30

Brief Summary

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 kidney function after cardiopulmonary bypass cardiac surgery.

Conditions

Stellate Ganglion Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Stellate ganglion block

For patients in Group S, left SGB was performed after the first TEE examination. The patient's head was tilted to the right. A high-frequency probe (6-13 MHz) was placed between the C6 and C7 transverse processes to obtain the best image of the longus colli muscle. After iodine disinfection, a 22-G atraumatic needle for peripheral nerve blocks (B. Braun Melsungen AG, Melsungen, Germany) was used to puncture the site posterior to the left carotid artery and on the surface of the longus colli muscle via an in-plane technique. Then,5 mL of 0.375% ropivacaine hydrochloride injection was administered provided that no blood, cerebrospinal fluid, or gas was suctioned out

Group Type: EXPERIMENTAL

Stellate ganglion block

Intervention Type: DRUG

After the induction of general anesthesia and before the start of the surgery,ultrasound-guided stellate ganglion block is performed, injecting 5 ml of 0.375% ropivacaine.

Control

Patients in Group C did not undergo the SGB procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stellate ganglion block

After the induction of general anesthesia and before the start of the surgery,ultrasound-guided stellate ganglion block is performed, injecting 5 ml of 0.375% ropivacaine.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients of any gender were eligible provided they were between the ages of 18 and 80 years;

2. American Society of Anesthesiologists (ASA) class of Ⅲ or IV.

Exclusion Criteria

1. emergency cardiac surgery；

2. major vascular surgery；

3. non-sinus rhythm, reoperation；

4. contraindications for TEE or SGB；

5. abnormal preoperative renal function；

6. severe preoperative heart failure with left ventricular ejection fraction < 30%, multi-organ dysfunction；

7. and severe infection requiring continuous antibiotic treatment;

8. enrolled in another clinical trial.

Elimination criteria:

1. incomplete follow-up data;

2. withdrawal during the procedure;

3. SGB failure or complications;

4. insufficient ultrasonographic imaging of the left renal artery on TEE;

5. repeated CPB during surgery;

6. need for cardiac assist devices (extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist devices) after CPB completion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20221107

Identifier Type: -

Identifier Source: org_study_id