]>
IRCT20231018059760N1 IRCT 2024-01-09 Mazandaran University of Medical Sciences 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 2024-01-10 anticipated 48 Complete https://irct.ir/trial/74827 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be placed in one of the two test groups (receiver of combined topical gel of diltiazem, papaverine and lidocaine) and control (placebo) by block randomization method. According to the 6 possible ways of placing letters in blocks of four, these blocks are numbered with numbers one to six. . (AABB1-ABBA2-BABA3-BBAA4-BABA5-ABAB6) Then, using Random Allocation Software 2.0, one of the numbers one to six will be randomly selected for 12 times. Each number will specify four placement modes in a block. Blocks of four will be placed in 12 non-transparent envelopes in numbered order according to the sequence of random selection and these envelopes will be sealed by someone outside the research team who is unaware of the research objectives and the allocation of people to the groups under study. . The envelopes will be opened in order and the patients will be assigned to the respective groups, Blinding description: It is in the form of three blinds. That is, both the participant and the researchers and the interventionist doctor and the nurse collecting the data will be blind to the placement of the patient in the intervention or placebo group. For this purpose, the drug and placebo will be prepared in same shape and without name labels tubes. These tubes are tagged A and B. Only the principal researcher will know which tube contains drug and which placebo. The patient, nurse and doctor of Cat.Lab. department, data collector and even the statistical analyzer will be unaware of the tubes contents. Patients will be randomly assigned to one of A or B groups in a block method. 3 Candidate patients for angiography and angioplasty through the radial artery. Intervention 1: Intervention group: recipient of combined topical gel. Intervention 2: Control group: receiving placebo gel. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is sss
public Amir Akbari Malekabadi
Taleb Amoli St., Fayaz Bakhsh St
Amol Iran (Islamic Republic of) 4771196571 +98 911 437 4611 Amirakbari0623@gmail.com Mazandaran University of Medical Sciences scientific Roghieh Nazari
Taleb Amoli St., Fayaz Bakhsh St
Amol Iran (Islamic Republic of) ۴۶۱۷۹۳۳۵۸۶ +98 911 125 6405 rnazari@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 Treatment - Drugs Placebo Intervention group: recipient of combined topical gel Control group: receiving placebo gel 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. 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. Mazandaran University of Medical Sciences Approved 2023-12-09 Research Ethics Committees of Mazandaran University of Medical Sciences Moallem Sq Sari Mazandaran Iran (Islamic Republic of)