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IRCT20220524054981N1 IRCT 2022-07-25 Semnan University of Medical Sciences Evaluation of the effect of epinephrine doses in head and neck surgeries 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 2022-07-23 anticipated 80 Complete https://irct.ir/trial/63817 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 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. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying subjects. Main results can also be shared after the study is completed. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: If researchers working in academic and scientific institutions submit a request to use the data in future related research, the data will be usable. Where to obtain: through the e-mail address of the researcher : pantea zahedinia : panteaazahedinia @gmail.com How to obtain: 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. Comments:
public Pantea zahedinia
Helal ahmar Ave
Qazvin Iran (Islamic Republic of) 3418637968 +98 28 3323 2621 panteaazahedinia@gmail.com Semnan University of Medical Sciences scientific Pantea zahedinia
Helal ahmar Ave
Qazvin Iran (Islamic Republic of) 3418637968 +98 28 3323 2621 panteaazahedinia@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) All patient ( non hypertensive ) that are candidate for head and neck surgeries aged 16_70 16 years 70 years Both Age < 16 and age > 70 Hypertention Treatment - Surgery Treatment - Surgery Treatment - Surgery 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. 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 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 Changes in blood pressure. Timepoint: During the surgery. Method of measurement: Monitoring. Cardiac arrhythmias. Timepoint: During the surgery. Method of measurement: Monitoring. The amount of bleeding during the operation. Timepoint: during the surgury. Method of measurement: Check list. Number of times required for topical injection of epinephrine in the operation field. Timepoint: Dِِِuring the surgery. Method of measurement: Check list. Semnan University of Medical Sciences Approved 2022-06-27 ethics committee of semnan university of medical sciences Golestan Semnan Semnan Iran (Islamic Republic of)