Evaluation of the efficacy of topical cerosomes of Menthol on radial spasm in patients underwent trans-radial angiography
Design
Phase 3 randomized triple-blinded placebo parallel clinical trial on 276 patients Randomization using Randomaization.com
Settings and conduct
This study will be performed on patients who underwent trans-radial angiography in the heart ward of Ghaem Hospital in Mashhad. Patients are randomly assigned to Menthol and placebo groups.
Randomization will be done using a block method with a block size of 4
The blocked randomization method is used with the volume of each block of four. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who underwent trans-radial angiography; Consent to admission to the study; Age over 18 years.
Exclusion criteria: Allergy to topicam Menthol.
Intervention groups
Intervention group: Patients who underwent trans-radial angiography and topical cerosomes of Menthol will be applied 30 minutes before PCI.
Placebo group: Patients who underwent trans-radial angiography and topical cerosomes of placebo will be applied 30 minutes before PCI.
Main outcome variables
Radial artery spasm during procedure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N15
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of topical cerosomes of Menthol on radial spasm in patients underwent trans-radial angiography
Public title
Evaluation of the efficacy of topical cerosomes of Menthol on radial spasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent radial angiography
Consent to admission to the study
Age more than 18 years old
Exclusion criteria:
Allergy to topical menthol
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
276
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used.
The volume of each block will be four. Then the list of possible blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 69 blocks according to the sample size of 276. Then random numbers between 1 and 69 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers. Sealed envelopes will be used to conceal allocation. A person not involved in sampling and data collection will prepare envelopes and randomize allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad
Radial artery spasm score: A) Verbal or nonverbal expression of discomfort in the forearm during catheter/sheath manipulation: Absent: 0; Present: 1; B) Difficulty in manipulating the catheter: Absent: 0; Present: 1; C) Difficulty in sheath removal: Absent: 0; Present: 1; D) Additional use of intraarterial vasodilator for suspected radial artery spasm: No: 0; Yes: 1. Incidence of radial artery spasm indicated by a Radial artery spasm score of 1 or more.
Secondary outcomes
1
Description
Patient pain
Timepoint
During radial canulation
Method of measurement
According to the VAS scale (0-10; 0 is the least and 10 is the most pain)
2
Description
Sympathetic system response
Timepoint
Before and after angioplasty
Method of measurement
Measuring of systolic blood pressure, diastolic blood pressure and heart rate using blood pressure monitors and pulse oximeter
Intervention groups
1
Description
Intervention group: Patients who underwent trans-radial angiography and 1 gram topical cerosomes of Menthol is applied to the wrist overlying radial pulse (centered approximately 1 cm proximal to the radial styloid process) 30 minutes before arterial puncture. Cerosomes of Menthol will be provided by Daru Azma Rasa Gostar Fartak company.
Category
Treatment - Drugs
2
Description
Control group: Patients who underwent trans-radial angiography and 1 gram of placebo topical cerosomes is applied to the wrist overlying radial pulse (centered approximately 1 cm proximal to the radial styloid process) 30 minutes before arterial puncture. Cerosomes of placebo will be provided by Daru Azma Rasa Gostar Fartak company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3801 2739
Email
Baradaranrv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available