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IRCT20150106020588N8 IRCT 2022-08-13 Esfahan University of Medical Sciences Comparison of the effects of Atropine and Tetracaine on Oculo Cardiac Reflex (OCR) in strabismus surgery Comparison of the effectiveness of preoperative administration of intravenous Atropine and topical Tetracaine on the incidence and severity of Oculo Cardiac Reflex (OCR) in strabismus surgery 2018-04-21 anticipated 120 Complete https://irct.ir/trial/64654 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is a simple randomized clinical trial in which patients entered the study groups by lottery; The medicines and placebo were placed in sealed, opaque, and similar form packets which were coded. Each code was also written on a piece of paper, folded, and placed inside a box. After entering the operating room, each patient took one of the papers out of the box; The pocket with the same number was the intervention that was applied to him. This process continued till the number of patients reached the desired one, Blinding description: This is a triple-blind clinical trial; In this way, before obtaining consent, patients were informed about the study but didn't know which group they would be in and therefore were blind. Also, the researcher who recorded the patient's symptoms was different from the nurse who injected the drug and didn't know the type of drug and was blind. Analysts who analyzed the data collected during the study also didn't know the type of intervention applied in each group and were blind. 3 Strabismus. Intervention 1: Intervention group 1: Patients in this group after inducting of anesthesia using 5 mg/kg of Thiopental sodium manufactured by Elixir Company, an amount of 0.5 mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company, and the amount of 2 M/kg of Fentanyl manufactured by Aburihan Company, after preparing the eyes and allowing access to the operation site by the surgeon, they received 0.5 mg of Atropine manufactured by Caspian Pharmaceutical Company intravenously, as well as maintenance of anesthesia using Propofol 100 mg/kg/min was administered. the patient's symptoms were measured and recorded until the end of the operation and then during recovery. Intervention 2: Intervention group 2: Patients in this group after inducting of anesthesia using 5 mg/kg of Thiopental sodium manufactured by Elixir Company, an amount of 0.5 mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company, and the amount of 2 M/kg of Fentanyl manufactured by Aburihan Company, after preparing the eyes and allowing access to the operation site by the surgeon, They received 3 to 5 drops of 0.5% topical Tetracaine made by Sinadaro in 4 directions on the eyeball. as well as maintenance of anesthesia using Propofol 100 mg/kg/min was administered. the patient's symptoms were measured and recorded until the end of the operation and then during recovery. Intervention 3: Control group : Patients in this group after inducting of anesthesia using 5 mg/kg of Thiopental sodium manufactured by Elixir Company, an amount of 0.5 mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company, and the amount of 2 M/kg of Fentanyl manufactured by Aburihan Company, after preparing the eyes and allowing access to the operation site by the surgeon, They received 3 to 5 drops of Artificial tears made by Sinadaro in 4 directions on the eyeball. as well as maintenance of anesthesia using Propofol 100 mg/kg/min was administered. the patient's symptoms were measured and recorded until the end of the operation and then during recovery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dariush Moradi Farsani
Hezar jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8597 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dariush Moradi Farsani
Hezar jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8597 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate for Strabismus surgery Age 10 to 70 years ASA class I and II informed consent to enter the study 10 years 70 years Both Allergic to Atropine, Tetracaine and artificial tears Cardiovascular diseases history H50 Other strabismus Prevention Prevention Placebo Intervention group 1: Patients in this group after inducting of anesthesia using 5 mg/kg of Thiopental sodium manufactured by Elixir Company, an amount of 0.5 mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company, and the amount of 2 M/kg of Fentanyl manufactured by Aburihan Company, after preparing the eyes and allowing access to the operation site by the surgeon, they received 0.5 mg of Atropine manufactured by Caspian Pharmaceutical Company intravenously, as well as maintenance of anesthesia using Propofol 100 mg/kg/min was administered. the patient's symptoms were measured and recorded until the end of the operation and then during recovery. Intervention group 2: Patients in this group after inducting of anesthesia using 5 mg/kg of Thiopental sodium manufactured by Elixir Company, an amount of 0.5 mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company, and the amount of 2 M/kg of Fentanyl manufactured by Aburihan Company, after preparing the eyes and allowing access to the operation site by the surgeon, They received 3 to 5 drops of 0.5% topical Tetracaine made by Sinadaro in 4 directions on the eyeball. as well as maintenance of anesthesia using Propofol 100 mg/kg/min was administered. the patient's symptoms were measured and recorded until the end of the operation and then during recovery. Control group : Patients in this group after inducting of anesthesia using 5 mg/kg of Thiopental sodium manufactured by Elixir Company, an amount of 0.5 mg/kg of Atracurium manufactured by Caspian Pharmaceutical Company, and the amount of 2 M/kg of Fentanyl manufactured by Aburihan Company, after preparing the eyes and allowing access to the operation site by the surgeon, They received 3 to 5 drops of Artificial tears made by Sinadaro in 4 directions on the eyeball. as well as maintenance of anesthesia using Propofol 100 mg/kg/min was administered. the patient's symptoms were measured and recorded until the end of the operation and then during recovery. Heart Rate. Timepoint: Before induction, immediately after the induction of anesthesia and then every 5 minutes to 30 minutes, and then every 10 minutes until the end of the surgery. Method of measurement: ECG monitoring. Blood Pressure. Timepoint: Before induction, immediately after the induction of anesthesia and then every 5 minutes to 30 minutes, and then every 10 minutes until the end of the surgery. Method of measurement: Sphygmomanometer. Surgery Duration. Timepoint: From the moment of surgical intervention to the end of eye dressing. Method of measurement: Timer. Esfahan University of Medical Sciences Approved 2020-06-11 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)