Comparison of the effect of epinephrine injection with two different concentrations on hemodynamic changes and bleeding rate of rhinoplasty in patients under general anesthesia
Comparing hemodynamic changes and bleeding rate of rhinoplasty surgery by injecting two different concentrations of epinephrine in patients under general anesthesia can help determine the target concentration of epinephrine in rhinoplasty surgery.
Design
Randomized double-blind clinical trial with a parallel group design; case and control with 30 patient in each group
Settings and conduct
Patients undergoing elective rhinoplasty surgery at Shafa hospital in Kerman after obtaining informed consent randmally will be assigned to case and control groups and will be induced anesthesia with same drugs.
The mean arterial blood pressure limit is maintained between 60-65 mm Hg with remifentanil infusion.
After induction of anesthesia, in the first group (control), lidocaine 2% with adrenaline with a concentration of 1/100000 is given to the surgeon for subcutaneous injection and In the other group (case), lidocaine 2% is used in combination with adrenaline at a concentration of 1/200000.(Surgeons and anesthesiologist are unaware of the concentration of the injection material so that double-sided blinding is established.) Heart rate and blood pressure will be recorded before and after induction ofanesthesia then 1.3.5minutes after injection and every 5 minutes until end of surjury also volume of bleeding will be recorded.
Participants/Inclusion and exclusion criteria
Admission requirements: age range 16-45 years old; ASA class I ,II.
Conditions prohibiting patients from entering: coagulation disorder; heart disease; hypertension; cerebrovascular disease; renal disease; drug allergies.
Intervention groups
In intervention group solution of lidocaine 2% with epinephrine 1/200000 and in control group solution of lidocaine 2% with epinephrine 1/100000 will be injected
Main outcome variables
Systolic blood pressure; diastolic blood pressure; heart rate; mean arterial blood pressure; bleeding during surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190911044743N1
Registration date:2020-06-14, 1399/03/25
Registration timing:prospective
Last update:2020-06-14, 1399/03/25
Update count:0
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Mahdieh Sharifzadehkermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3247 4199
Email address
m_sharifzadeh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of epinephrine injection with two different concentrations on hemodynamic changes and bleeding rate of rhinoplasty in patients under general anesthesia
Public title
Comparison of the effect of epinephrine injection in rhinoplasty
Patients will be assigned to case or control group according to restricted allocation method and random allocation rule. Allocation concealment will be with sequentially sealed envelopes and technician who is responsible for checking inclusion and exclusion criteria.
Blinding (investigator's opinion)
Double blinded
Blinding description
For all patients, the same forms are filled out by anesthesia technician in charge of the patient.The participant, the filling form technician, the surgeon and the anesthesiologist are not aware of which group the patient is in..Epinephrine with a concentration of 1/200000 or 1/1000000 is prepared by the surgeon's assistant nurse and is given to the surgeon for injection.At the end of anesthesia and after completing the form, the mark of group A or B is written on the forms by the person in charge of collecting the forms.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Beginning of Ibn Sina street-first Jahad boulevard-Somayeh intersection (Tahmasb Abad)-Kerman-Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.KMU.REC.1398.572
Health conditions studied
1
Description of health condition studied
effect of subcutaneus epinephrine on hemodynamic changes and bleeding in rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Systolic and diastolic and mean arterial pressure
Timepoint
Before inductin by anesthesia, after intubation and then at intervals before anesthesia, after intubation, immediately before epinephrine injection, and then every minute to the third minutes after injection, and then every 5 minutes until the end of the procedure.
Method of measurement
Non-invasive automatic measurement by a monitoring device
2
Description
Heart rate
Timepoint
Before inductin by anesthesia, after intubation and then at intervals before anesthesia, after intubation, immediately before epinephrine injection, and then every minute to the third minutes, and then every 5 minutes until the end of the procedure.
Method of measurement
EKG monitoring
3
Description
Rate of bleeding
Timepoint
End of surgury
Method of measurement
Measurment of blood in bottle of suction and number of bloody gases
Secondary outcomes
1
Description
Volume of infused propofol
Timepoint
End of surgery
Method of measurement
Volume of infusion in milliliter
2
Description
Volume of infused remifentanil
Timepoint
End of surgery
Method of measurement
Volume of infusion in milliliter
Intervention groups
1
Description
Intervention group: solution of subcutaneus epinephrine 1/200000 with lidocaine 2%
Category
Treatment - Drugs
2
Description
Control group: subcutaneus epinephrine 1/100000 with lidocaine 2%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Shafa Hospital
Full name of responsible person
Mahdieh Sharifzadeh Kermani
Street address
Shafa Medical Training Center,Kosar Boulevard,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
msharifzade78@gmail.com
Web page address
http://sh.kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Afzalipour Medical School,Shahid Bahonar University,end of 22 Bahman Boulevard,Kerman
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3325 7660
Email
medicalschool@kmu.ac.ir
Web page address
http://sm.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohadeseh Ahmadi
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Afzalipour Medical School, Shahid Bahonar University, end of 22 Bahman Boulevard, Kerman
City
kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3325 7660
Email
mohadeseh7265@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdieh Sharifzadeh Kermani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Afzalipour Medical School, Shahid Bahonar University, end of 22 Bahman Boulevard, Kerman
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3325 7660
Email
msharifzade78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdieh Sharifzadeh Kermani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Afzalipour Medical School, Shahid Bahonar University, end of 22 Bahman Boulevard, Kerman
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3325 7660
Email
msharifzade78@gmail.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 can be shared
When the data will become available and for how long
After completing the statistical design and analysis, all data are reviewed, analyzed and accessible.
Start access one month after printing the results
To whom data/document is available
Data are available to academic and scientific researchers
Under which criteria data/document could be used
I don't have any specific conditions yet
From where data/document is obtainable
Refer to the person in charge of scientific accountability
What processes are involved for a request to access data/document
After e-mail and message to the person responsible for scientific response and its review, about a week later, the request will be answered