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IRCT20160307026950N48 IRCT 2022-12-11 Esfahan University of Medical Sciences The effect of Atracurium and Cis-Atracurium injection on hemodynamic status and Neutrophil-to-Lymphocyte Ratio (NLR) during anesthesia induction Comparison of the effect of Atracurium and Cis-Atracurium injection on hemodynamic status and Neutrophil-to-Lymphocyte Ratio (NLR) during anesthesia induction 2022-11-06 anticipated 80 Complete https://irct.ir/trial/66985 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: This is a simple randomized clinical trial that patients are divided into groups based on flipping a coin; After the first flip of the coin, for the first patient, atracurium is selected for injection in the case of heads, and in the case of tails, cis atracurium is selected. Then, from the second patient onwards, individuals enter the groups one by one until the number reaches 40 people in each group, Blinding description: This is a double-blind clinical trial so that, before obtaining consent, the patients will be informed of the study but will not be informed about the type of intervention received. Also, the researchers responsible for collecting and analyzing the data won't be informed about the intervention group; therefore, they are all blind. 2 Change in hemodynamic status and NLR. Intervention 1: Intervention group A: In this group, after placing the patients on the surgical bed and connecting the monitoring and establishing two suitable intravenous lines, the first venous blood sample is taken for cell counting and the patient's initial clinical symptoms are measured and recorded. Then, 5 mg/kg Sodium Thiopental made by Elixir Pharmaceutical Company, 100 micrograms of Fentanyl made by Caspin Pharmaceutical Company and 0.5 mg/kg of Atracurium made by Aburihan Pharmaceutical Company are injected to induce anesthesia. Sampling and recording of symptoms are also done in 3, 10 and 20 minutes after anesthesia. Intervention 2: Intervention group B: In this group, after placing the patients on the surgical bed and connecting the monitoring and establishing two suitable intravenous lines, the first venous blood sample is taken for cell counting and the patient's initial clinical symptoms are measured and recorded. Then, 5 mg/kg Sodium Thiopental made by Elixir Pharmaceutical Company, 100 micrograms of Fentanyl made by Caspin Pharmaceutical Company and 0.15 mg/kg of Cis-Atracurium made by Aburihan Pharmaceutical Company are injected to induce anesthesia. Sampling and recording of symptoms are also done in 3, 10 and 20 minutes after anesthesia. 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 Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 65 years old Anesthesia class I and II according to ASA criteria Candidate for anesthesia with Atracurium and Cis-Atracurium Informed consent to enter the study 18 years 65 years Both Obesity or BMI (Body Mass Index) of more than 30 History of cardiovascular diseases and hemodynamic disorders or myocardial infarction in the last 6 months Taking psychoactive drugs, antihistamines and corticosteroids in the last week Addiction to opioid and non-opioid drugs Pregnancy and breastfeeding Having diabetes, orthostatic hypotension, bradycardia, hypokalemia, hypothyroidism, depression, long QT syndrome, asthma and allergies Diagnosis Diagnosis Intervention group A: In this group, after placing the patients on the surgical bed and connecting the monitoring and establishing two suitable intravenous lines, the first venous blood sample is taken for cell counting and the patient's initial clinical symptoms are measured and recorded. Then, 5 mg/kg Sodium Thiopental made by Elixir Pharmaceutical Company, 100 micrograms of Fentanyl made by Caspin Pharmaceutical Company and 0.5 mg/kg of Atracurium made by Aburihan Pharmaceutical Company are injected to induce anesthesia. Sampling and recording of symptoms are also done in 3, 10 and 20 minutes after anesthesia. Intervention group B: In this group, after placing the patients on the surgical bed and connecting the monitoring and establishing two suitable intravenous lines, the first venous blood sample is taken for cell counting and the patient's initial clinical symptoms are measured and recorded. Then, 5 mg/kg Sodium Thiopental made by Elixir Pharmaceutical Company, 100 micrograms of Fentanyl made by Caspin Pharmaceutical Company and 0.15 mg/kg of Cis-Atracurium made by Aburihan Pharmaceutical Company are injected to induce anesthesia. Sampling and recording of symptoms are also done in 3, 10 and 20 minutes after anesthesia. Heart Rate. Timepoint: before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia. Method of measurement: Electrocardiogram. Blood Pressure. Timepoint: before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia. Method of measurement: Sphygmomanometer. Oxygen saturation. Timepoint: before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia. Method of measurement: Pulse Oximeter. Neutrophil to lymphocyte ratio. Timepoint: before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia. Method of measurement: Cell count of venous blood sample. Esfahan University of Medical Sciences Approved 2022-09-11 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)