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IRCT20200825048515N43 IRCT 2021-10-02 Esfahan University of Medical Sciences The effect of different doses of labetalol on bleeding volume during and after dacryocystorhinostomy surgery The evaluation of the effect of different doses of labetalol on bleeding volume during and after dacryocystorhinostomy surgery 2021-10-23 anticipated 84 Complete https://irct.ir/trial/59049 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 84 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into three groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the three study groups, Blinding description: In order to achieve the triple-blind study, different doses of labetalol and placebo (without labetalol) will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Dacryocystorhinostomy. Intervention 1: First intervention group: In this group, labetalol at a dose of 0.2 mg / kg will be administered as an infusion 5 minutes after induction of anesthesia. Intervention 2: The second intervention group: In this group, labetalol at a dose of 0.4 mg / kg will be administered as an infusion 5 minutes after induction of anesthesia. Intervention 3: Control group: In this group, placebo will be administered as an infusion 5 minutes after induction of anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Daroush Moradi Farsani
Feiz Hospital, Ayatollah Modarres Street, Ghods Square, Isfahan.
Isfahan Iran (Islamic Republic of) 8149644874 +98 31 3445 2034 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Daroush Moradi Farsani
Feiz Hospital, Ayatollah Modarres Street, Ghods Square, Isfahan.
Isfahan Iran (Islamic Republic of) 8149644874 +98 31 3445 2034 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate for elective dacryocystorhinostomy surgery Age range 20 to 64 years Class I and II classification of the American Society of Anesthesiologists 20 years 64 years Both History of blood diseases, coagulopathy Allergy to labetalol Existence of any uncontrolled systemic disease Recent use of anticoagulants History of malignant hyperthermia H04.0 Dacryoadenitis Treatment - Drugs Treatment - Drugs Placebo First intervention group: In this group, labetalol at a dose of 0.2 mg / kg will be administered as an infusion 5 minutes after induction of anesthesia. The second intervention group: In this group, labetalol at a dose of 0.4 mg / kg will be administered as an infusion 5 minutes after induction of anesthesia. Control group: In this group, placebo will be administered as an infusion 5 minutes after induction of anesthesia. Bleeding volume. Timepoint: During surgery and in recovery. Method of measurement: Measure the amount of blood in the suction. Systolic blood pressure. Timepoint: Immediately before surgery and then every 15 minutes during surgery and then every 15 minutes to an hour in recovery. Method of measurement: Monitoring device. Diastolic blood pressure. Timepoint: Immediately before surgery and then every 15 minutes during surgery and then every 15 minutes to an hour in recovery. Method of measurement: Monitoring device. Mean Arterial Pressure. Timepoint: Immediately before surgery and then every 15 minutes during surgery and then every 15 minutes to an hour in recovery. Method of measurement: Monitoring device. Hear rate. Timepoint: Immediately before surgery and then every 15 minutes during surgery and then every 15 minutes to an hour in recovery. Method of measurement: Monitoring device. Isfahan University of Medical Sciences Approved 2021-04-28 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)