Comparative study of the effectiveness of fentanyl with and without nitroglycerine spray on hemodynamic response due to laryngoscopy and endotracheal intubation
Copaarison of the effectiveness of fentanyl with and without nitroglycerine spray on hemodynamic response due to laryngoscopy and endotracheal intubation
Design
This study is a one-blinded clinical trial. The study population will be all patients referred to Imam Reza hospital of Kermanshah. 40 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study that will be conducted in Imam Reza hospital of Kermanshah is a one-blinded one that Tthe data analyzer was kept blind to the allocation of study groups. All patients will be hydrated with 7 ml/kg of Ringerlactate prior to drug administration. Hemodynamic changes including heart rate, systolic and diastolic blood pressure are recorded prior to drug administration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60 years; No history of heart disease or stroke, high blood pressure, and drug use and addiction accidentally; Patients who have had laryngoscopy more than once
Exclusion criteria: Patients with diabetes; The data analyzer was kept blind to the allocation of study groups
Intervention groups
The first intervention group will receive fentanyl 2 µg / kg. The second intervention group will receive two puffs of nitroglycerin spray (400 micrograms) with fentanyl 2 μg / kg for 5 min before tracheal intubation (anesthesia induction) and laryngoscopy intravenously for 30 seconds.
Main outcome variables
blood pressure, heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N142
Registration date:2020-03-17, 1398/12/27
Registration timing:prospective
Last update:2020-03-17, 1398/12/27
Update count:0
Registration date
2020-03-17, 1398/12/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-07, 1399/01/19
Expected recruitment end date
2020-07-09, 1399/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of fentanyl with and without nitroglycerine spray on hemodynamic response due to laryngoscopy and endotracheal intubation
Public title
Comparative study of the effectiveness of fentanyl with and without nitroglycerine spray on hemodynamic response due to laryngoscopy and endotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60 years
No history of heart disease or stroke, high blood pressure, and drug use and addiction accidentally
Exclusion criteria:
Patients who have had laryngoscopy more than once
Patients with diabetes
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into three groups of 20. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the first intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the second intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer was kept blind to the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
ir.kums.rec.1398.1202
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
I46.9
ICD-10 code description
Cardiac arrest, cause unspecified
Primary outcomes
1
Description
blood pressure
Timepoint
Before starting the study, before laryngoscopy and intubation and at 10 and 1,3,5,7 minutes, after laryngoscopy and endotracheal intubation
Method of measurement
Using a barometer
2
Description
heart beat
Timepoint
Before starting the study, before laryngoscopy and intubation and at 10 and 1,3,5,7 minutes, after laryngoscopy and endotracheal intubation
Method of measurement
Using the pacemaker
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive fentanyl 2 µg / kg
Category
Treatment - Drugs
2
Description
The second intervention group will receive two puffs of nitroglycerin spray (400 micrograms) with fentanyl 2 μg / kg for 5 min before tracheal intubation (anesthesia induction) and laryngoscopy intravenously for 30 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Javad Nazari
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sajad.nazari90@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
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 Nazari
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sajad.nazari90@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. javad Aminisaman
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Aminisaman399@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Javad Nazari
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sajad.nazari90@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail