search
Back to results

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

Primary Purpose

Stellate Ganglion Block

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate ganglion block
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stellate Ganglion Block focused on measuring Stellate ganglion block, Postoperative acute kidney injury, Renal blood flow

Eligibility Criteria

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

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.

Sites / Locations

  • the Affiliated Hospital of Yangzhou University, Yangzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stellate ganglion block

Control

Arm Description

Outcomes

Primary Outcome Measures

Changes in renal blood flow
Renal blood flow indicators
Indicators of kidney function
Cystatin C,
Changes in left ventricular systolic function
EDV, ESV, EF are assessed by TEE
Changes in right ventricular systolic function
Right ventricular systolic function changes, such as TAPSE, are assessed by TEE
Changes in right ventricular diastolic function
Right ventricular diastolic function changes
Changes in blood flow in the coronary sinuse
TEE assessment of coronary sinus flow changes, such as maximum systolic flow,
Changes in myocardial performance index
ET, IVCT, IVRT are measured by TEE to calculate the myocardial performance index
Changes in cerebral blood flow
Cerebral flow tests are performed by TCD, such as systolic peak flow velocity (Vs),

Secondary Outcome Measures

Changes in the level of Cardiac output
The above results should be measured immediately after induction, at the beginning
Changes in the level of SVR
The above results should be measured immediately after induction, at the beginning
Changes in the level of SVRI
The above results should be measured immediately after induction, at the beginning

Full Information

First Posted
November 6, 2022
Last Updated
December 5, 2022
Sponsor
Yangzhou University
search

1. Study Identification

Unique Protocol Identification Number
NCT05652179
Brief Title
Effect of Stellate Ganglion Block on Cardiac and Renal Function After Cardiopulmonary Bypass Cardiac Surgery
Official Title
Effect of Stellate Ganglion Block on Cardiac and Renal Function After Cardiopulmonary Bypass Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University

4. Oversight

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

5. Study Description

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 heart and kidney function after cardiopulmonary bypass cardiac surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stellate Ganglion Block
Keywords
Stellate ganglion block, Postoperative acute kidney injury, Renal blood flow

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stellate ganglion block
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Stellate ganglion block
Intervention Description
Before anesthesia induction, ultrasound-guided stellate ganglion block is performed, injecting 7 ml of 0.375% ropivacaine.
Primary Outcome Measure Information:
Title
Changes in renal blood flow
Description
Renal blood flow indicators
Time Frame
30 minutes after the start of the operation , 30 minutes after the start of cardiopulmonary , 30 minutes after the end of cardiopulmonary bypassbypass
Title
Indicators of kidney function
Description
Cystatin C,
Time Frame
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
Title
Changes in left ventricular systolic function
Description
EDV, ESV, EF are assessed by TEE
Time Frame
from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery
Title
Changes in right ventricular systolic function
Description
Right ventricular systolic function changes, such as TAPSE, are assessed by TEE
Time Frame
from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery
Title
Changes in right ventricular diastolic function
Description
Right ventricular diastolic function changes
Time Frame
from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery
Title
Changes in blood flow in the coronary sinuse
Description
TEE assessment of coronary sinus flow changes, such as maximum systolic flow,
Time Frame
from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery
Title
Changes in myocardial performance index
Description
ET, IVCT, IVRT are measured by TEE to calculate the myocardial performance index
Time Frame
from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery
Title
Changes in cerebral blood flow
Description
Cerebral flow tests are performed by TCD, such as systolic peak flow velocity (Vs),
Time Frame
The day before surgery , 30 min after the start of extracorporeal bypass , 30 minutes after the end of extracorporeal bypass
Secondary Outcome Measure Information:
Title
Changes in the level of Cardiac output
Description
The above results should be measured immediately after induction, at the beginning
Time Frame
into ICU 30 minutes
Title
Changes in the level of SVR
Description
The above results should be measured immediately after induction, at the beginning
Time Frame
into ICU 30 minutes
Title
Changes in the level of SVRI
Description
The above results should be measured immediately after induction, at the beginning
Time Frame
into ICU 30 minutes

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Zhang, professor
Phone
+8615062791355
Email
zhangzhuancg@163.com
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Zhang, professor
Phone
+8615062791355
Email
zhangzhuanjy@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs