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IRCT20180416039326N16 IRCT 2020-11-30 Esfahan University of Medical Sciences Comparative Study of the Effectiveness of Two Different Doses of Intravenous Labetalol on Cardiovascular Response to Tracheal Extubation Comparative Study of the Effectiveness of Two Different Doses of Intravenous Labetalol on Cardiovascular Response to Tracheal Extubation 2021-01-19 anticipated 72 Complete https://irct.ir/trial/52339 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using a list of random numbers generated by computer, patients are assigned to each three groups based on the permutation blocks method with blocks with a volume of 6, Blinding description: The patient and the observer who collects the information will be unaware of the drug grouping. 2-3 Tracheal Extubation. Intervention 1: Intervention group 1: In this group, a syringe containing labetalol (0.1 mg / kg diluted with 0.9% saline to a volume of 5 ml) will be injected. Intervention 2: Intervention group 2: In this group, a syringe containing labetalol (0.2 mg / kg, diluted with 0.9% saline to a volume of 5 ml) will be injected. Intervention 3: Control group: In this group Syringe containing 5 ml of 0.9% saline will be injected. Yes - There is a plan to make this available What will be shared: Unidentifiable individual data including hemodynamic indices and complications in all three groups can be shared. When: 6 months after publication of paper To whom: Academic and medical researchers Conditions: Use for research and treatment purposes Where to obtain: Email of the person in charge of public accountability: Hamidshetabi@med.mui.ac.ir Dr Hamidreza Shetabi How to obtain: If possible, it will be sent via email up to a maximum of 1 month after applying. Comments:
public Hamidreza Shetabi
Al-Zahra Hospital; Sofe bolevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidraza Shetabi
Al-Zahra Hospital; Sofe bolevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Normotensive patients who are candidates for elective surgery less than two hours under general anesthesia requiring endotracheal intubation Age between 20 to 60 years ASA one and two Informed consent to participate in the study Weight 55 to 85 kilogram 20 years 60 years Both Pregnant women Diabetic patients Patients with uncontrolled underlying cardiovascular disease Baseline heart rate less than 60 beats per minute and systolic blood pressure less than 90 mmHg Patients with cerebrovascular diseases Contraindication of the use of study medicines Known allergy to anesthetics in the study Opioid abuse Taking medicines with cardiovascular effects Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, a syringe containing labetalol (0.1 mg / kg diluted with 0.9% saline to a volume of 5 ml) will be injected. Intervention group 2: In this group, a syringe containing labetalol (0.2 mg / kg, diluted with 0.9% saline to a volume of 5 ml) will be injected. Control group: In this group Syringe containing 5 ml of 0.9% saline will be injected. Systolic blood pressure. Timepoint: Before extubation and 1, 3, 5 and 10 minutes after extubation. Method of measurement: Barometer. Diastolic blood pressure. Timepoint: Before extubation and 1, 3, 5 and 10 minutes after extubation. Method of measurement: Barometer. Pulse rate. Timepoint: Before extubation and 1, 3, 5 and 10 minutes after extubation. Method of measurement: Pulse oximetry. Oxygen saturation percentage. Timepoint: Before extubation and 1, 3, 5 and 10 minutes after extubation. Method of measurement: Pulse oximetry. Mean arterial pressure. Timepoint: Before extubation and 1, 3, 5 and 10 minutes after extubation. Method of measurement: Barometer. Duration of staying in recovery. Timepoint: Based on minutes from arrival to reaching the modified aldrete score of 9. Method of measurement: Information collection form. Adverse airway response. Timepoint: During the time of staying in recovery. Method of measurement: Information collection form. Hemodynamic complications. Timepoint: During the time of staying in recovery. Method of measurement: Information collection form. Duration of extubation. Timepoint: Based on minutes from the time of discontinuing anesthetics to the time of extubation. Method of measurement: Information collection form. Esfahan University of Medical Sciences Approved 2020-10-17 Ethics committee of Isfahan University of Medical Sciences Hezarjarib Blvd, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)