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IRCT20160307026950N30 IRCT 2021-01-12 Esfahan University of Medical Sciences The effect of Labetalol on bleeding during lumbar spine fusion surgery Comparison of the effect of two different doses of Labetalol on the rate of bleeding in lumbar spine fusion surgeries 2021-01-20 anticipated 64 Complete https://irct.ir/trial/53454 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this trial, there are two intervention groups, A and B, and randomization is done by assigning even and odd; In this way, patients are numbered according to their arrival time, then individual numbers enter group A and even numbers enter group B, until their number reaches 32 people in each group. Therefore, there is no directional choice and patients enter groups completely randomly, Blinding description: This is a double-blind study; As the clinical caregiver is different from the person injecting the drug and is unaware of the type of intervention, the surgeon and patients are also unaware of the type of intervention applied and are therefore blind. 2-3 Bleeding rate during lumbar spine fusion surgery. Intervention 1: Intervention group A: After anesthesia, patients in this group receive Labetalol at a dose of 0.25 mg per kg body weight for 10 seconds, and then 2 mg / min as an infusion. Intervention 2: Intervention group B: After anesthesia, patients in this group receive Labetalol in the amount of 0.25 mg per kg of body weight for 10 seconds, and then 4 mg / min as an infusion. 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 Heydar Almazy
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 dr.haidara@hotmail.com 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 50 years Candidate for lumbar spine fusion surgery ASA Class I and II Anesthesia 18 years 50 years Both History of any allergy to Labetalol History of heart block History of lung diseases such as asthma M45 Ankylosing spondylitis Prevention Prevention Intervention group A: After anesthesia, patients in this group receive Labetalol at a dose of 0.25 mg per kg body weight for 10 seconds, and then 2 mg / min as an infusion. Intervention group B: After anesthesia, patients in this group receive Labetalol in the amount of 0.25 mg per kg of body weight for 10 seconds, and then 4 mg / min as an infusion. The amount of bleeding during the operation. Timepoint: After surgical incision until the end of the operation. Method of measurement: Counting the number of blood gases and measuring the amount of sucked blood. Heart Rate. Timepoint: Before surgery, during anesthesia, after anesthesia until the end of the operation, from the beginning of recovery to exit it. Method of measurement: ECG monitoring. Blood Pressure. Timepoint: Preoperative time, anesthesia time, every 10 minutes from the start of the operation until the end of the recovery. Method of measurement: Barometer. Percentage of arterial blood oxygen saturation. Timepoint: Before surgery, during anesthesia, after anesthesia until the end of the operation, from the beginning of recovery to exit it. Method of measurement: Pulse Oximeter. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2020-09-23 Isfahan University of Medical Sciences Committe for Ethics in Biomedical Research Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)