search
Back to results

Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery of Patients Undergoing Cardiac Valve Replacement and Its Mechanism

Primary Purpose

Left Stellate Ganglion Block Can Quickly Restore the Left Stellate Ganglion, Possible Molecular Mechanism of Left Stellate Ganglion Block

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stellate ganglion block
Sponsored by
Zhonghua Chen,MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Left Stellate Ganglion Block Can Quickly Restore the Left Stellate Ganglion focused on measuring ultrasound-guided、 left stellate ganglion block 、on rapid rehabilitation in patients with cardiac Valve replacement

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Sixty patients with cardiac Valve replacement undergoing elective cardiopulmonary bypass, with cardiac function class II-IV and ASAII-IV, aged 18-70 years.

Exclusion Criteria:

- Patients with off-pump cardiac Valve replacement, age > 18 years or > 70 years, cardiac function ≥ III, ASA grade ≥ III, local anesthetic allergy, concomitant immune disease or immunosuppressive status, patients with severe mental disorders who could not cooperate with SGB, abnormal neck anatomy, and failure of stellate ganglion block refused to participate in the study.

Sites / Locations

  • Zhonghua Chen,MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Control group

Arm Description

the test group was injected with 0.5% ropivacaine 6ml.

The control group was injected with 6ml normal saline

Outcomes

Primary Outcome Measures

Postoperative complications
Pulmonary infection, oxygenation injury, malignant arrhythmia, hemorrhage, enteroparalysis, incision infection, renal insufficiency, cognitive dysfunction and so on

Secondary Outcome Measures

Mortality
Mortality

Full Information

First Posted
October 16, 2022
Last Updated
October 16, 2022
Sponsor
Zhonghua Chen,MD
Collaborators
Shaoxing Hospital of Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT05587023
Brief Title
Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery of Patients Undergoing Cardiac Valve Replacement and Its Mechanism
Official Title
Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery of Patients Undergoing Cardiac Valve Replacement and Its Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhonghua Chen,MD
Collaborators
Shaoxing Hospital of Zhejiang 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
In this study, Valve replacement patients undergoing cardiopulmonary bypass were randomly divided into control group and experimental group (SGB Group) , main outcome measures: postoperative complications (pulmonary infection, oxygenation injury, arrhythmia, hemorrhage, enteroparalysis, incision infection, renal insufficiency, cognitive impairment, etc.) and 30-day mortality. Secondary outcome measures: Hemodynamics, postoperative extubation time, length of stay and total cost of hospitalization. To investigate the effect of SGB on the rapid recovery of patients with Valve replacement heart disease after cardiopulmonary bypass.
Detailed Description
The aim of this study was to investigate the effect of left stellate ganglion block on the incidence and severity of postoperative complications in patients with cardiac Valve replacement undergoing cardiopulmonary bypass, to compare the difference of inflammatory reaction between the control group and the stellate ganglion block group at different time points, and to preliminarily elucidate the molecular mechanism of stellate ganglion block in the protection of cardiac Valve replacement during cardiopulmonary bypass (CPB) . The first part is a prospective study on the effect of left stellate ganglion block on cardiac Valve replacement Hemodynamics during cardiopulmonary bypass (CPB) , the incidence, length of hospital stay, cost of hospital stay, and 30-day mortality of the common Valve replacement complications after cardiopulmonary bypass (pulmonary infection, oxygenation injury, arrhythmia, bleeding, intestinal paralysis, incision infection, renal insufficiency, cognitive impairment, etc.) , to determine the effect of left stellate ganglion block on rapid recovery from cardiac Valve replacement during cardiopulmonary bypass. In the second part, we collected the dynamic changes of inflammatory factors in plasma of control group and patients with stellate ganglion block before and 1,3,6,24 and 72 hours after operation, to explore the molecular mechanisms by which left stellate ganglion block promotes rapid recovery and reduces severe complications in patients with cardiac Valve replacement undergoing cardiopulmonary bypass (CPB) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Stellate Ganglion Block Can Quickly Restore the Left Stellate Ganglion, Possible Molecular Mechanism of Left Stellate Ganglion Block
Keywords
ultrasound-guided、 left stellate ganglion block 、on rapid rehabilitation in patients with cardiac Valve replacement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty patients with cardiac Valve replacement undergoing cardiopulmonary bypass were randomly divided into experimental group and control group, with 30 patients in each group. All patients signed the informed consent form. Control Group: the control group was injected with 6ml normal saline. Test group: the test group was injected with 0.5% ropivacaine 6ml.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Neither the experimenters nor the participants knew whether they were taking a Experimental drug or a placebo. To be as objective as possible, the description of the treatment effects and adverse reactions of the subjects, as well as the recording of the various reactions of the experimenters, should be given.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
the test group was injected with 0.5% ropivacaine 6ml.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group was injected with 6ml normal saline
Intervention Type
Procedure
Intervention Name(s)
stellate ganglion block
Intervention Description
The experimental group was given 6ml ropivacaine for stellate ganglion block. In the control group, 6ml saline was used for stellate ganglion block.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
Pulmonary infection, oxygenation injury, malignant arrhythmia, hemorrhage, enteroparalysis, incision infection, renal insufficiency, cognitive dysfunction and so on
Time Frame
within 1 week after operation
Secondary Outcome Measure Information:
Title
Mortality
Description
Mortality
Time Frame
Within 30 days after surgery
Other Pre-specified Outcome Measures:
Title
The concentration of blood factors in plasma
Description
Plasma levels of IL-6, IL-10 and TNF-α were measured by enzyme-linked immunosorbent assay (Elisa) at 1,3,6,24 and 72 h after operation.
Time Frame
Within 3 days after surgery

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Sixty patients with cardiac Valve replacement undergoing elective cardiopulmonary bypass, with cardiac function class II-IV and ASAII-IV, aged 18-70 years. Exclusion Criteria: - Patients with off-pump cardiac Valve replacement, age > 18 years or > 70 years, cardiac function ≥ III, ASA grade ≥ III, local anesthetic allergy, concomitant immune disease or immunosuppressive status, patients with severe mental disorders who could not cooperate with SGB, abnormal neck anatomy, and failure of stellate ganglion block refused to participate in the study.
Facility Information:
Facility Name
Zhonghua Chen,MD
City
Shaoxing
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Ultrasound-guided Left Stellate Ganglion Block on Rapid Recovery of Patients Undergoing Cardiac Valve Replacement and Its Mechanism

We'll reach out to this number within 24 hrs