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Completed

NCT Number: NCT02343276

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group).

Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

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Key information

Conditions

Cardiac Catheterisation Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Cardiologia de Santa Catarina

São Jose, Santa Catarina, 88000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for cardiac catheterization
  • Suitable candidates for transradial approach

Exclusion criteria

  • AMI
  • Intubated patients
  • Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)
  • Prior inclusion in this trial

Treatment and study plan

Nitroglycerin

Drug

Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion

Other names: Tridil

Placebo

Other

Placebo (saline solution 10 ml) in radial artery after sheath insertion

Other names: Saline solution

Primary outcomes

  1. Pain Assessment Using Visual Analogue Scale

    Time frame: Five minutes after sheath removal

    the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.

Secondary outcomes

  1. Procedure Duration

    Time frame: Immediate

    Procedure duration, from artery catheterization up to removal of sheath.

  2. Radiation Exposure

    Time frame: Immediate

    Total radiation required to complete the procedure.

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia de Santa Catarina

Other

Registry information

Official study title

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2015
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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