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IRCT20221119056535N1 IRCT 2022-12-18 Qazvin University of Medical Sciences Investigating the effect of Remifentanil and Labtalol on hemodynamic changes Investigating the effect of Remifentanil and Labtalol, in combination with Propofol, on hemodynamic changes in nasal endoscopy 2022-12-20 anticipated 50 Complete https://irct.ir/trial/66917 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who met the necessary conditions, after completing the personal informed consent form to the trial in a simple random manner using blue and red color cards placed in a container and the patient himself chooses the color of his choice. They enter one of the two experimental and control groups. 3 Condition 1: Hemodynamic changes. Condition 2: Bleeding rate. Condition 3: arrhythmia. Intervention 1: Intervention group 1: Patients who met the necessary conditions, after full training by an anesthesiologist and filling in the patient's informed personal consent form, entered the study and were randomly assigned to experimental group A (remifentanil combined with propofol). Dose of drugs: Remifentanil: the onset of anesthesia starts with 1 to 5 mcg/kg/minute. If an endotracheal tube is inserted for the patient within 8 minutes, an initial dose of 1 mcg/kg in 30-60 Seconds are also given to maintain anesthesia: 1 mcg/kg/min can be infused every 2-5 minutes. The dose can be increased by 25-100% or decreased by 25-50% every 2-5 minutes. Propofol: within 15 seconds and with a dose of 2 mg/kg based on the weight of the study group, it is injected through a tee along with 10 cc of normal saline. Intervention 2: Intervention group 2: Patients who met the necessary conditions, after full training by the anesthesiologist and filling out the patient's informed personal consent form, entered the study and were randomly assigned to experimental group B (labtalol in combination with propofol). Dosage of drugs: labtalol: 20 mg intravenous injection once and then, if there is no effect, as an infusion of 2-0.5 mg per minute up to a maximum dose of 300 mg and propofol: within 15 seconds and with a dose of 2 mg/kg based on The weight of the study group is injected with 10 cc of normal saline through a tee. 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 Need more advice
public Khashayar Shahverdi
No 1, Floor 10, Kasra 5, Nokhbegan square
Qazvin Iran (Islamic Republic of) 3415866563 +98 21 2270 7778 kh.shahverdi@qums.ac.ir Qazvin University of Medical Sciences scientific Khashayar Shahverdi
No 1, Floor 10, Kasra 5, Nokhbegan square
Qazvin Iran (Islamic Republic of) 3415866563 +98 21 2270 7778 kh.shahverdi@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study The age of the person should be between 15 and 60 years There is no history of surgery and it is the patient's first surgery Not having a chronic mental or physical illness (schizophrenia, diabetes, etc.) Not having vision and hearing problems and other disabilities No allergy to Remifentanil, Profol and Labtalol Absence of pregnancy, breastfeeding and abortion less than 3 months 15 years 60 years Both Heart diseases and HTN Liver diseases (cirrhosis, hepatitis, etc.) I49.9 Cardiac arrhythmia, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: Patients who met the necessary conditions, after full training by an anesthesiologist and filling in the patient's informed personal consent form, entered the study and were randomly assigned to experimental group A (remifentanil combined with propofol). Dose of drugs: Remifentanil: the onset of anesthesia starts with 1 to 5 mcg/kg/minute. If an endotracheal tube is inserted for the patient within 8 minutes, an initial dose of 1 mcg/kg in 30-60 Seconds are also given to maintain anesthesia: 1 mcg/kg/min can be infused every 2-5 minutes. The dose can be increased by 25-100% or decreased by 25-50% every 2-5 minutes. Propofol: within 15 seconds and with a dose of 2 mg/kg based on the weight of the study group, it is injected through a tee along with 10 cc of normal saline. Intervention group 2: Patients who met the necessary conditions, after full training by the anesthesiologist and filling out the patient's informed personal consent form, entered the study and were randomly assigned to experimental group B (labtalol in combination with propofol). Dosage of drugs: labtalol: 20 mg intravenous injection once and then, if there is no effect, as an infusion of 2-0.5 mg per minute up to a maximum dose of 300 mg and propofol: within 15 seconds and with a dose of 2 mg/kg based on The weight of the study group is injected with 10 cc of normal saline through a tee Bleeding. Timepoint: First, three minutes after the start of induction, then three and five minutes and then ten minutes. Method of measurement: ECG, pulse oximeter, non-invasive blood pressure measurement. Qazvin University of Medical Sciences Approved 2022-11-16 Ethics Committee of Qazvin University of Medical Sciences Unit 1, 10 floor, Kasra tower 5, Nokhbegan square Qazvin Qazvin Iran (Islamic Republic of)