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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 catheterization

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 catheterization

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231018059760N1
Enrollment
48
Registered
2024-01-09
Start date
2024-01-10
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidate patients for angiography and angioplasty through the radial artery.

Interventions

Intervention 1: Intervention group: recipient of combined topical gel. Intervention 2: Control group: receiving placebo gel.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Number 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Akbari Malekabadi

Mazandaran University of Medical Sciences

Amirakbari0623@gmail.com+98 911 437 4611

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026