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

Sponsor

Zhonghua Chen,MD (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05587023

Collaborator

Shaoxing Hospital of Zhejiang University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Left Stellate Ganglion Block Can Quickly Restore the Left Stellate Ganglion Possible Molecular Mechanism of Left Stellate Ganglion Block	Procedure: stellate ganglion block	N/A

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) .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group the test group was injected with 0.5% ropivacaine 6ml.	Procedure: stellate ganglion block The experimental group was given 6ml ropivacaine for stellate ganglion block. In the control group, 6ml saline was used for stellate ganglion block.
Placebo Comparator: Control group The control group was injected with 6ml normal saline	Procedure: stellate ganglion block The experimental group was given 6ml ropivacaine for stellate ganglion block. In the control group, 6ml saline was used for stellate ganglion block.

Arm

Intervention/Treatment

Experimental: Test group

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

Procedure: stellate ganglion block

The experimental group was given 6ml ropivacaine for stellate ganglion block. In the control group, 6ml saline was used for stellate ganglion block.

Placebo Comparator: Control group

The control group was injected with 6ml normal saline

Procedure: stellate ganglion block

The experimental group was given 6ml ropivacaine for stellate ganglion block. In the control group, 6ml saline was used for stellate ganglion block.

Outcome Measures

Primary Outcome Measures

Postoperative complications [within 1 week after operation]
Pulmonary infection, oxygenation injury, malignant arrhythmia, hemorrhage, enteroparalysis, incision infection, renal insufficiency, cognitive dysfunction and so on

Secondary Outcome Measures

Mortality [Within 30 days after surgery]
Mortality

Other Outcome Measures

The concentration of blood factors in plasma [Within 3 days after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhonghua Chen,MD	Shaoxing	Zhejiang	China

Sponsors and Collaborators

Zhonghua Chen,MD
Shaoxing Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhonghua Chen,MD, Head of anesthesiology, Shaoxing Hospital of Zhejiang University

ClinicalTrials.gov Identifier:

NCT05587023

Other Study ID Numbers:

2021-K-Y-294-01

First Posted:

Oct 19, 2022

Last Update Posted:

Oct 19, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhonghua Chen,MD, Head of anesthesiology, Shaoxing Hospital of Zhejiang University

ultrasound-guided、 left stellate ganglion block 、on rapid rehabilitation in patients with cardiac Valve replacement

Additional relevant MeSH terms:

Ganglion Cysts

Synovial Cyst

Study Results

No Results Posted as of Oct 19, 2022