Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Instituto de Cardiologia de Santa Catarina328 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

328

Conditions

Cardiac Catheterisation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain Assessment Using Visual Analogue Scale

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.

Time frame: Five minutes after sheath removal

Secondary Outcomes

Procedure Duration

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

Time frame: Immediate

Radiation Exposure

Total radiation required to complete the procedure.