UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061056 |
|---|---|
| Receipt number | R000069853 |
| Scientific Title | Efficacy of ultrasound-guided stellate ganglion block in the prevention of perioperative myocardial injury in high-risk patients undergoing noncardiac surgery |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/25 16:42:22 |
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Basic information
Public title
Efficacy of ultrasound-guided stellate ganglion block in the prevention of perioperative myocardial injury in high-risk patients undergoing noncardiac surgery
Acronym
SGB and MINS
Scientific Title
Efficacy of ultrasound-guided stellate ganglion block in the prevention of perioperative myocardial injury in high-risk patients undergoing noncardiac surgery
Scientific Title:Acronym
SGB and MINS
Region
| Asia(except Japan) |
Condition
Condition
The trail aims to enrol 300 patients and follow them for 60 days. Eligible patients must have significant cardiovascular risk factors, be aged 45 years or older, and be scheduled for elective surgery under general anaesthesia with an anticipated duration of 1hour or more.
Classification by specialty
| Cardiology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The trial aimed to verify whether a single preoperative stellate ganglion block could reduce the incidence of perioperative myocardial injury in patients with cardiovascular risk factors undergoing noncardiac surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the incidence of myocardial injury, defined as any myocardial infarction or any elevated troponin I level (exceeding the upper reference limit), deemed to be attributable to myocardial ischaemia, occurring within the first 30 days after the initiation of surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
In the stellate ganglion block (SGB) arm, patients will be assigned to receive the right SGB under ultrasound guidance. Patients will lie supine with a slightly extended neck, and a high frequency ultrasound transducer probe will be positioned transversely at the C7 level. At the C6 level, a 22 gauge needle will be laterally inserted, with the needle tip positioned posterior to the carotid artery and anterior to the longus colli muscle using an in plane approach. Subsequently, a single 5mL dose of 0.5% ropivacaine will be administered to the stellate ganglion after confirming the absence of blood through negative aspiration. A successful SGB is indicated by the signs of Horner's syndrome. Additionally, monitoring facial temperature and index finger perfusion index will serve as adjunctive measures to confirm successful blockade.
Interventions/Control_2
Patients in the control arm received an equal volume of saline solution, which could not be visually identified from ropivacaine by the blind anesthesiologist. Both groups of patients received identical standardized protocols for anesthesia induction, maintenance, and postoperative sedation.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Patients aged 45 years or older, scheduled for elective laparoscopic or open major surgery under general anesthesia, with an expected operative duration of 1 hour or more and an anticipated hospital stay of 3 days or longer.
2, At least three of the following risk factors: age over 65 years; history of peripheral artery disease; history of ischemic heart disease; history of congestive heart failure; history of stroke or transient ischaemic attack; serum creatinine >2.0 mg/dL; diabetes requiring medication; hypertension requiring medication; current smoking or smoking cessation for less than 2 years.
Key exclusion criteria
1, Coagulation disorders.
2, Localised skin infection.
3, Glaucoma.
4, Thyroid disorders.
5, Cardiac conduction abnormalities.
6, Patients with psychiatric disorders unable to cooperate.
7, Pregnant women.
8, Allergy to investigational drugs used in the trial.
9, Septicaemia.
10, Preoperative treatment with positive inotropic agents.
11, Severe heart failure (defined as ejection fraction <30%).
12, Acute cardiac conditions.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66293462
cjandsh@tmmu.edu.cn
Public contact
Name of contact person
| 1st name | Jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66293462
Homepage URL
cjandsh@tmmu.edu.cn
Sponsor or person
Institute
Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Institute
Department
Personal name
Funding Source
Organization
Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the People's Hospital of Chongqing Banan District
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing 401320, P.R China
Tel
+81-086-23-66291798
409560509@qq.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069853
