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

NCT05587023 | Unknown

• 1 other identifier: 2021-K-Y-294-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

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

  within 1 week after operation

Secondary Outcomes (1)

• Mortality

  Within 30 days after surgery

Other Outcomes (1)

• The concentration of blood factors in plasma

  Within 3 days after surgery

Study Arms (2)

Test group

EXPERIMENTAL

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

Procedure: stellate ganglion block

Control group

PLACEBO COMPARATOR

The control group was injected with 6ml normal saline

Procedure: stellate ganglion block

Interventions

stellate ganglion block PROCEDURE

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

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Zhonghua Chen,MD: lead
• Shaoxing Hospital of Zhejiang University: collaborator

Study Sites (1)

Zhonghua Chen,MD

Shaoxing, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)