Clinical trial NCT05587023: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Shaoxing Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shaoxing Hospital of Zhejiang University
First posted: 2022-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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) .

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.

Primary outcomes:
measure: Postoperative complications
timeFrame: within 1 week after operation
Secondary outcomes:
measure: Mortality
timeFrame: Within 30 days after surgery
Other outcomes:
measure: The concentration of blood factors in plasma
timeFrame: Within 3 days after surgery
Locations:
city: Shaoxing
country: China
facility: Zhonghua Chen,MD
state: Zhejiang
Study officials:
References: