The effect of Laryngeal Mask Airway impregnation with diltiazem gel on cardiovascular changes in patients with hypertension undergoing Fico surgery
Design
Clinical trial with control group and parallel groups, double blind, simple randomization
Settings and conduct
In patients in the intervention group, a laryngeal airway mask impregnated with diltiazem gel was used, and in patients in the control group, lubricant gel was used. The gels were named A and B by the research partner, and the researcher and patient were unaware of the type of gel.
Participants/Inclusion and exclusion criteria
Inclusion criteria: HTN patients undergoing Fico surgery with 16 to 55 years old,
Exclusion criteria: Dysrhythmia, heart attack, pregnancy
Intervention groups
The intervention group includes patients with hypertension undergoing Fico surgery who receive Diltiazem gel intervention.
The control group includes patients with hypertension undergoing Fico surgery who receive Lubricant gel intervention.
Main outcome variables
Hypertension, heart rate, dysrhythmia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047457N1
Registration date:2020-05-26, 1399/03/06
Registration timing:prospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
javad aminisaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3727 9104
Email address
j.aminisaman@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Laryngeal Mask Airway impregnation with diltiazem gel on cardiovascular changes in patients with hypertension undergoing Fico surgery
Public title
Investigation of the effect of diltiazem gel on cardiovascular changes in patients with hypertension undergoing Fico surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
HTN patients under Fico surgery
Age range: 16 to 55 years old
Exclusion criteria:
Dysrhythmia
Heart attack
Pregnancy
Age
From 16 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by random number table method
Blinding (investigator's opinion)
Double blinded
Blinding description
Researchers and participants have been kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Research Ethics Committee
Street address
Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.KUMS.REC.1399.131
Health conditions studied
1
Description of health condition studied
HTN patients
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
2
Description of health condition studied
Fico surgery
ICD-10 code
H59.029
ICD-10 code description
Cataract (lens) fragments in eye following cataract surgery
Primary outcomes
1
Description
hypertension
Timepoint
Before intubation, immediately after intubation and 5 min after intubation, during the operation every 15 minutes, the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Based on the monitoring device
Secondary outcomes
1
Description
Cardiac dysrhythmia
Timepoint
Before intubation, immediately after intubation and 5 min after intubation, during the operation every 15 minutes, the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Based on the monitoring device
2
Description
heart beat
Timepoint
Before intubation, immediately after intubation and 5 min after intubation, during the operation every 15 minutes, the recovery, 15 and 30 minutes after entering the recovery
Method of measurement
Based on the monitoring device
Intervention groups
1
Description
Control group: In the first intervention group, induction of anesthesia is performed with 2 mg / kg pro-pofol and atracurium 0.5 mg / kg, then the laryngeal airway mask is soaked in water-soluble neutral sterile lubricant gel.
Category
Treatment - Other
2
Description
Intervention group: In the second intervention group, induction of anesthesia is performed with 2 mg / kg of propofol and atracurium 0.5 mg / kg, then the laryngeal airway mask with 0.2% gel is dipped in water-soluble sterile diltiazem.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Kermanshah
Full name of responsible person
Javad Amini Saman
Street address
Imam Khomeini Hospital, Naqlieh St. , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
ihosp@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Deputy of Research and Technology, Building No. 2, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719995364
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Javad Amini Saman
Position
Managing Director of Imam Khomeini Hospital in Kermanshah
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Naqlieh St. , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
j.aminisaman@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Javad Amini Saman
Position
Managing Director of Imam Khomeini Hospital in Kermanshah
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Naqlieh St. , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Email
j.aminisaman@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
sharmin rahmani
Position
Researcher of Imam Khomeini Hospital Research Unit in Kermanshah
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Imam Khomeini Hospital, Naqlieh St. , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 2049
Email
sh.rahmani90@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared
When the data will become available and for how long
Access period starting one year after the publication of results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Use for future researchs
From where data/document is obtainable
Kermanshah University of Medical Sciences
What processes are involved for a request to access data/document