Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Phase 3

Completed

• Conditions: Cardiac Catheterisation
• Interventions: Other: Placebo; Drug: Nitroglycerin

• Registration Number: NCT02343276
• Lead Sponsor: Instituto de Cardiologia de Santa Catarina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-21
• Study Start: 2015-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2018-09-28
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-14
• Last Update Submitted: 2019-02-14
• Results First Posted: 2019-05-31
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain Assessment Using Visual Analogue Scale	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 Outcome Measures

Name	Time	Method
Procedure Duration	Immediate	Procedure duration, from artery catheterization up to removal of sheath.
Radiation Exposure	Immediate	Total radiation required to complete the procedure.

Trial Locations

Locations (1)

Instituto de Cardiologia de Santa Catarina; 🇧🇷 São Jose, SC, Brazil