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IRCT20160430027677N12 IRCT 2019-02-22 Oroumia University of Medical Sciences The effect of Tizanidine premedication on blood loss and the quality of the surgical field Comparison the effect of oral Tizanidine and placebo on blood loss and the quality of the surgical field during endoscopic paranasal sinus surgery 2016-05-20 anticipated 60 Complete https://irct.ir/trial/36964 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned into two groups of tizanidine 4mg (group T) and placebo (group P) using Random Allocation Software 2.0, and the target codes will be written on a piece of paper and placed in sealed envelopes with sequential allocation, Blinding description: The drug will be administered by the nurse in the ward and at the time of admission, the anesthesiologist will be unaware which patient will be assigned to which group. Drug containers will be identical and only the nurse will know about the contents of each of them, and finally, after collecting information by the resident in training in anesthesiology, the anesthesiology specialist will be informed of the group each patient is assigned to. 2-3 bleeding. Intervention 1: Intervention group: patients will receive tizanidine 6 mg oral tablet, 90 minutes before surgery. Intervention 2: Control group: will receive oral placebo 90 minutes before surgery. 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 No more information
public Shahryar Sane
Orjanse alley, Resalat blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences scientific Shahryar Sane
Orjanse alley, Resalat blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Being at the age of 25 to 55 years old ASA (American Society of Anesthesiologists) class I Chronic sinusitis 25 years 55 years Both Patients in whom controlled decreasing blood pressure is contraindicated Liver and kidney failure Known sensitivity to tizanidine Systolic blood pressure above 160 and diastolic blood pressure above 90 mmhg Heart rate below 50 per minute Patients who have received anticoagulant, beta blocker, calcium channel blocker or digoxin Treatment - Drugs Placebo Intervention group: patients will receive tizanidine 6 mg oral tablet, 90 minutes before surgery. Control group: will receive oral placebo 90 minutes before surgery. Amount of bleeding. Timepoint: during surgery. Method of measurement: Measuring the amount of blood inside the suction device and the gases used. Quality of the surgical field. Timepoint: During surgery. Method of measurement: Boezaart scale. Pain. Timepoint: At recovery and 6 hours after surgery. Method of measurement: visual analog scale. Mean arterial pressure. Timepoint: Every 15 minutes during surgery. Method of measurement: Non invasive pressure gauge. Oroumia University of Medical Sciences Approved 2016-10-26 Ethics commitee of Urmia University of Medical Sciences Orjanse alley, Resalat blvd Urmia West Azarbaijan Iran (Islamic Republic of)