Radial spasm during cardiac catheterization MedDRA version: 19.1 Level: PT Classification code 10003175 Term: Arterial spasm System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: EMLA 25mg/g + 25mg/g crema
Pharmaceutical Form: Cream
INN or Proposed INN: LIDOCAINE
Current Sponsor code: 61.096
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Conce
Sponsors
ÁREA DE ATENCIÓN INTEGRADA DE ALBACETE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age > 18 years old • Signing of informed consent • Elective diagnostic cardiac catheterization with radial access intention. • 5 French sheath Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 608 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Allergy or intolerance to any of the medicines used in the study • Systolic blood pressure < 90 mmHg • Inability to understand the study or to provide the informed consent • Patient under chronic oral anticoagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the incidence of radial artery spasm and the gain of caliber with the use of different vasodilators and anaesthetic topic cream.;Secondary Objective: • To assess the radial-radial and radial-femoral crossover rate with each one of the strategies. • To evaluate the incidence of vaso-vagal reactions needing for treatment in each group of the study. • To assess different parameters related to pain during arterial puncture. • Subjective evaluation of pain and confortability perceived by patients through analogical scales and dedicated tests. • Subjective evaluation of difficulty in arterial puncture and grade of radial spasm perception by the operator through dedicated tests.;Primary end point(s): • Radial artery spasm • Gain of caliber according the formula: ((postVD MLD – preVD MLD)/ preVD MLD) x100 (VD: Vasodilator, MLD: Minimum Lumen Diameter);Timepoint(s) of evaluation of this end point: Cross-sectional study, only one visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Radial-Radial and Radial-Femoral crossover • Vaso-vagal reaction • Pain scales for patients • Confortability scales for patients • Difficulty scales for physicians;Timepoint(s) of evaluation of this end point: Cross-sectional study, only one visit | — |
Countries
Spain
Contacts
Public ContactMedical Department
ANTEIC, S.L.
Outcome results
None listed