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Evaluation and comparison of the results and complications caused by the injection of 1/1,000,000, 1/500,000 and 1/200,000 dilutions of epinephrine in normal saline in the surgical field, on patients who are candidates for head and neck surgery, a clinical trial

Protocol summary

Study aim
Determining the optimal dilution of epinephrine, which while reducing the amount of bleeding in the surgical field, has the least cardiovascular complications, including changes in blood pressure and cardiac arrhythmias, and in addition, we see the lowest amount of flap necrosis
Design
Three-group randomized clinical trial with parallel and double-blind groups. Randomized with random blocks, phase 2-3 on 80 patients.
Settings and conduct
This study was performed in Kosar Hospital of Semnan province on patients who are candidates for head and neck surgeries by diluting epinephrine vials of 1 in 10,000 to the three dilutions mentioned above as topical injection during surgery with blue needle syringes and parallel to it. Bleeding is monitored in the operation field and changes in patients' heart rate and rhythm and blood pressure are performed The patient does not know which group he is placed in, and the care personnel will not know how the patients are assigned to the groups and the results of the intervention. The study information is not obvious to the statistician and will be identified by the letters A, B, C. This study will be double-blind .
Participants/Inclusion and exclusion criteria
Patients aged 16_70 non hypertensive . candidate for head and neck surguries
Intervention groups
Three groups: in the first group (A), for surgical injection of epinephrine with a dilution of 1 in 200,000 and in the second group (B) of epinephrine with a dilution of 1 in 500,000 and in the third group (C) of epinephrine with a dilution of 1 At 1,000,000
Main outcome variables
Number of epinephrine injections required per group; bleeding amount in field ;blood pressure changes during surgury; arythmies during surgury

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220524054981N1
Registration date: 2022-07-25, 1401/05/03
Registration timing: registered_while_recruiting

Last update: 2022-07-25, 1401/05/03
Update count: 0
Registration date
2022-07-25, 1401/05/03
Registrant information
Name
pantea zahedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 2621
Email address
panteaazahedinia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the results and complications caused by the injection of 1/1,000,000, 1/500,000 and 1/200,000 dilutions of epinephrine in normal saline in the surgical field, on patients who are candidates for head and neck surgery, a clinical trial
Public title
Evaluation of the effect of epinephrine doses in head and neck surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patient ( non hypertensive ) that are candidate for head and neck surgeries aged 16_70
Exclusion criteria:
Age < 16 and age > 70 Hypertention
Age
From 16 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples (into three groups) is done randomly using the Block Randomization method with 9 blocks of 9 assigned to three groups. In this method, A represents group one (injection of epinephrine during surgery with a dilution of 1 in 200,000), B represents group two (injection of epinephrine during surgery with a dilution of 1 in 500,000), and C represents group three (injection of epinephrine during surgery with a dilution of 1 in 500,000). The dilution will be one in 1,000,000). In this way, the sequence of interventions A, B, and C in the form of blocks from number 1 to 10 is determined by the plan's epidemiologist consultant and given to the executive supervisor of the plan, and the researcher receives assignments from the executive supervisor to assign each eligible person. slow First, the executive supervisor selects the block using random numbers (the assignment list will be prepared with the help of the epidemiologist consultant and before starting the work based on the random numbers created through Excel software (between 0 and 1)) and then the people Qualified persons are assigned to one of the three groups A, B or C according to the pre-determined order by the epidemiologist consultant. It should be mentioned that if a block is selected based on random numbers and all 9 sequences have already been filled in it, another random number will be selected for that individual. More about this source textSource text required for additional translation information Send feedback Side panels
Blinding (investigator's opinion)
Double blinded
Blinding description
The sample selection process in the groups will be done by the researcher and the day before the operation. Therefore, the patient does not know which group he is placed in, and the care personnel will not know how the patients are assigned to the groups and the results of the intervention. The study information is not obvious to the statistician and will be identified by letters A, B, C. This study will be double-blind (surgeon and statistician will be unaware of the patient group). The day before the operation, the researcher will obtain informed and written consent from the people to participate in the study if they meet the criteria for entering the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of semnan university of medical sciences
Street address
Golestan
City
Semnan
Province
Semnan
Postal code
99951-35198
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.SEMUMS.REC.1401.077

Health conditions studied

1

Description of health condition studied
Optimal and optimal dilution of epinephrine, which, while reducing the amount of bleeding in the surgical field, has the least cardiovascular complications, including changes in blood pressure and cardiac arrhythmias
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in blood pressure
Timepoint
During the surgery
Method of measurement
Monitoring

2

Description
Cardiac arrhythmias
Timepoint
During the surgery
Method of measurement
Monitoring

3

Description
The amount of bleeding during the operation
Timepoint
during the surgury
Method of measurement
Check list

4

Description
Number of times required for topical injection of epinephrine in the operation field
Timepoint
Dِِِuring the surgery
Method of measurement
Check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receive a dilution of 1 in 200,000 (Epinaline brand from Iran Hormon Company) to dilute epinephrine: First, we mix 1 cc of a 1/10000 vial of epinephrine with 9 cc of normal saline in a 10 cc syringe. The obtained dilution will be 1/100,000. Now, to prepare the 1/200,000 dilution, mix 1 cc of the 1/100,000 preparation with 1 cc of normal saline in a 2 cc syringe. How to administer epinephrine: in the surgical field using Injections are made from 2, 5, and 10 cc syringes with fine needle heads (blue color). In relation to the volume of diluted epinephrine in the surgical field: the injection volume varies between 50 and 200 cc, which depends on the type. It works, for example, in rhinoplasty, this amount is 50 cc, but in cranioplasty, it can be up to 100 cc.
Category
Treatment - Surgery

2

Description
Intervention group: Receive a dilution of 1 in 500,000 (Epinaline brand from Iran Hormon Company) to dilute epinephrine: First, we mix 1 cc of a 1/10000 vial of epinephrine with 9 cc of normal saline in a 10 cc syringe. The obtained dilution will be 1/100000. To prepare a dilution of 1/500000. Mix 1 cc of the prepared 1/100000 solution with 4 cc of normal saline in a 5 cc syringe. How to administer epinephrine: in the surgical field using 2, 5, and 10 cc syringes with fine needle heads (blue color) injection is performed in relation to the volume of diluted epinephrine in the surgical field: the injection volume varies between 50 and 200 cc, which depends on the type of operation, for example, in rhinoplasty, this amount is 50 cc But in cranioplasty, it can be up to 100 cc
Category
Treatment - Surgery

3

Description
Intervention group: Receive a dilution of 1 in 1000,000 (Epinaline brand from Iran Hormon Company) to dilute epinephrine: First, we mix 1 cc of a 1/10000 vial of epinephrine with 9 cc of normal saline in a 10 cc syringe. The obtained dilution will be 1/100000. To prepare a dilution of 1/1000000. Mix 1 cc of the prepared 1/100,000 solution with 9 cc of normal saline in a 10 cc syringe. How to administer epinephrine: in the surgical field using 2, 5, and 10 cc syringes with fine needle heads (blue The injection is performed in relation to the volume of diluted epinephrine in the surgical field: the injection volume varies between 50 and 200 cc, which depends on the type of operation, for example, in rhinoplasty, this amount is 50 cc, but In cranioplasty, up to 100 cc is possible
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Pantea Zahedinia
Street address
Golestan
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
+98 23 3343 7837
Email
kosarhos@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
pantea zahedinia
Street address
5 km of Damghan road
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Pantea zahedinia
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Helal ahmar Ave
City
Qazvin
Province
Qazvin
Postal code
3418637968
Phone
+98 28 3323 2621
Email
panteaazahedinia@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Pantea zahedinia
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Helal ahmar Ave
City
Qazvin
Province
Qazvin
Postal code
3418637968
Phone
+98 28 3323 2621
Email
panteaazahedinia@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Pantea zahedinia
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
pre general physician
Street address
Helal ahmar Ave
City
Qazvin
Province
Qazvin
Postal code
3418637968
Phone
+98 28 3323 2621
Email
panteaazahedinia@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 potentially be shared after de-identifying subjects. Main results can also be shared after the study is completed.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If researchers working in academic and scientific institutions submit a request to use the data in future related research, the data will be usable.
From where data/document is obtainable
through the e-mail address of the researcher : pantea zahedinia : panteaazahedinia @gmail.com
What processes are involved for a request to access data/document
6 months after the results are published, it is possible to receive the mentioned documents through the researcher's email address, which is provided to the applicants.
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