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

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

NCT ID: NCT05587023

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

Conditions: Official terms:
Ganglion Cysts
Synovial Cyst

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

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

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.

Primary purpose: Supportive Care

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.

Intervention:

Intervention type: Procedure
Intervention name: stellate ganglion block
Description: The experimental group was given 6ml ropivacaine for stellate ganglion block. In the control group, 6ml saline was used for stellate ganglion block.
Arm group label: Control group
Arm group label: Test group

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) .

Criteria for 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.

Gender: All

Gender based: Yes

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhonghua Chen,MD

Address:
City: Shaoxing
Country: China

Start date: January 1, 2021

Completion date: December 1, 2023

Lead sponsor:
Agency: Zhonghua Chen,MD
Agency class: Other

Collaborator:
Agency: Shaoxing Hospital of Zhejiang University
Agency class: Other

Source: Shaoxing Hospital of Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05587023