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Effect of stellate ganglion light irradiation with near-infrared light on arteriovenous fistula creation for hemodialysis: a double-blinded randomized controlled trial

Effect of stellate ganglion light irradiation with near-infrared light on arteriovenous fistula creation for hemodialysis: a double-blinded randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032240675
Enrollment
52
Registered
2025-02-13
Start date
2025-02-19
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage kidney disease

Interventions

This study is a single-center, prospective, placebo-controlled, double-blind, randomized controlled trial. The procedures are as follows: 1. Informed Consent: Surgeons A and B, who are co-investigator
SuperLizer
Stellate ganglion block

Sponsors

Ueda Kenichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are scheduled for arteriovenous fistula creation for hemodialysis. 2. Patients who have a sufficient understanding of the research and provide consent. 3. Patients who are 18 years of age or older at the time of obtaining consent.

Exclusion criteria

Exclusion criteria: 1. Patients with arterial vessel diameter at the planned arteriovenous fistula site of 1.5mm or less. 2. Patients with venous vessel diameter at the planned arteriovenous fistula site of 2mm or less after tourniquet 3. Patients with significant arterial sclerosis at the planned arteriovenous fistula site. 4. Patients with glaucoma. 5. Patients with cataracts. 6. Patients with BMI >= 35. 7. Patients with skin disorders at the planned irradiation site. 8. Patients who are considered unsuitable for participation in this study by the attending physician.

Design outcomes

Primary

MeasureTime frame
Changes in the diameter of the radial superficial vein (mm): Measurements are taken before and after irradiation using an ultrasound device. The measurements are performed after applying a manual blood pressure cuff set to 80 mmHg for at least 30 seconds.

Secondary

MeasureTime frame
1. Changes in Vascular Diameter (mm) Before and After Irradiation: - For veins, measurements are taken using an ultrasound device after applying a manual blood pressure cuff set to 80 mmHg for at least 30 seconds. - For arteries, no cuff application is required. The specific vessels to be measured include: 1.Radial Artery 2.Communicating Vein (defined as a vein connecting superficial and deep veins in the midline) 3.Median Vein 4.Brachial Artery 2. Immediate Postoperative Shunt Blood Flow and Vascular Diameter: - Measurements (blood flow: mL/s; vascular diameter: mm) are performed using an ultrasound device immediately after shunt creation. 3. Shunt Blood Flow and Vascular Diameter Two Weeks Post-Surgery: - Measurements (blood flow: mL/s; vascular diameter: mm) are performed using an ultrasound device during a routine outpatient visit. 4. Shunt Patency Rates at Two Weeks and Six Months Post-Surgery: - Patency Criteria: 1.If the dialysis shunt is in use and usable, it is considered patent. 2.If the dialysis shunt is not yet in use, patency is assessed comprehensively based on the following: - Auscultation for shunt sounds. - Palpation for shunt thrill. - Ultrasound Confirmation of blood flow. 5. Perioperative Complications: - Document and analyze any complications occurring during the perioperative period.

Contacts

Public ContactZhuan Jin

Kameda Medical Center

jin.zhuan@kameda.jp+81-4-7092-2211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026