The effect of the combined topical gel containing diltiazem, papaverine and lidocaine on hand function, pain, radial artery spasm and sympathetic tone in patients undergoing Trans radial cardiac catheterizatio

Phase 3

Recruiting

Conditions: Candidate patients for angiography and angioplasty through the radial artery.

Registration Number: IRCT20231018059760N1

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

Patients with coronary heart disease and clinical candidates for radial catheterization for diagnostic or therapeutic interventions.
Able to understand Persian language
Providing written consent
Age above 18 years
No previous pain and injury in the right hand

Exclusion Criteria

Atrioventricular block
QRS prolongation of more than 120 milliseconds
Parkinson's disease
Long QT intervals of more than 0.44 seconds
breastfeeding
pregnancy
Known liver dysfunction
Type D response in Barbeau test
Acute coronary syndrome
Raynaud's syndrome
Known history of hypersensitivity to local anesthetics
Radial pulse not palpable
Systolic blood pressure drop of less than 90 mmHg
More than two attempts to reach the radial artery
Lack of radial artery access and femoral access as an alternative solution
History of radial artery access in the last 6 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radial artery spasm. Timepoint: During catheterization. Method of measurement: Using the radial artery spasm scoring scale.;Hand function. Timepoint: before the start of catheterization and two hours after catheter removal. Method of measurement: Using the tool: HAKIR Questionnaire (HQ-8).;The pain. Timepoint: Before, during and after catheterization. Method of measurement: using visual analog scale (VAS).;Sympathetic tone. Timepoint: Before, during and after catheterization. Method of measurement: Using a hemodynamic monitoring device and a pulse oximeter.

Secondary Outcome Measures

Name	Time	Method
umber of attempts to access the radial artery. Timepoint: During catheterization. Method of measurement: It will be calculated as the number of passes of the needle through the skin and will be observed and recorded by the researcher.;Lack of access to the radial artery. Timepoint: During catheterization. Method of measurement: The sheath cannot be inserted or pressure is not detected.