Tokyo, March 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061056) titled 'Efficacy of ultrasound-guided stellate ganglion block in the prevention of perioperative myocardial injury in high-risk patients undergoing noncardiac surgery' on March 25.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Department of Anaesthesiology, People's Hospital of Chongqing Banan District
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 malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 45
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 Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 28 Day
Anticipated trial start date - 2026 Year 03 Month 15 Day
Last follow-up date - 2026 Year 03 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069853
Disclaimer: Curated by HT Syndication.
