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Nitroglycerin as Spasmolytic Regimen for RAS Prevention in Radial Center

A Randomized Comparison of Nitroglycerin Versus Placebo as Spasmolytic Regimen to Prevent Moderate to Severe Radial Artery Spasm in Radial Center

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03889470
Acronym
NORAS
Enrollment
1000
Registered
2019-03-26
Start date
2018-03-31
Completion date
2019-10-01
Last updated
2019-06-04

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

Conditions

Radial Artery Injury

Keywords

transradial catheterisation, radial artery spasm

Brief summary

The investigators will investigate whether administration of Nitroglycerin (NTG) as spasmolytic regimen reduces the incidence of moderate to severe radial artery spasm (RAS) in patients undergoing transradial catheterization in radial center.

Detailed description

Patients will be randomized to receive either 200 microgram NTG or placebo (saline) at the beginning of the procedure soon after radial sheath placement. The operators will be blinded to both assignment. The primary outcome is the incidence of moderate to severe RAS evaluated by the operators during the radial procedure. Both NTG and placebo will be administered using an identical syringe to keep the operators blinded to the treatment allocation. Radial angiogram is mandatory to measure the diameter of both radial and ulnar arteries. Doppler ultrasound of the radial artery will be examined at the day after the procedure.

Interventions

DRUGNTG 1 MG/ML Injectable Solution

administered after sheath placement

Sponsors

Hermina Heart Center Kemayoran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

NTG vs Placebo

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients undergoing transradial catheterisation using proximal radial artery puncture technique

Exclusion criteria

* Blood pressure \<100 mmHg * Refuse to participate

Design outcomes

Primary

MeasureTime frameDescription
The incidence of Moderate to severe radial artery spasmDuring the index procedurearm pain associated with catheter manipulation (RAS grade 2 to 4)

Countries

Indonesia

Contacts

Primary ContactAgnes Intan, MD
agnesintan1231@gmail.com622122608047

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026