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IRCT20110528006617N4 IRCT 2020-07-11 Esfahan University of Medical Sciences The effect of oral Clonidine and Tranexamic on blood loss during surgery Comparison the effect of oral Clonidine and Tranexamic acid before Surgery on blood loss in lumbar spine surgery 2019-09-23 anticipated 90 Complete https://irct.ir/trial/45432 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First with attention to the number of groups(3 groups)and the number of persons in every group, explained an amount of six block. So all of the situations that six person can stay on that block and stay on the study in form of couple in one of the triple group. After that randomized selection of the block with table of accidental numbers in fifteen times between all of the form in arrangement have done and fifteen blocks an amount of six selected, that allocated to every group two persons, Blinding description: We produced Placebo Capsule similar to Tranexamic Acid and Placebo tablets similar to Clonidine. The Tranexamic Acid group received 2 Capsules of Tranexamic Acid and one tablet of Placebo 2 hours before surgery, the Clonidine group received 2 Capsules of Placebo and one tablett of Clonidine 2 hours before surgery, the Placebo group received 2 Capsules of Placebo and one tablett of Placebo 2 hours before surgery. So the patients do not have any information about the intervention and the person who registered the information do not know which patient in which group ist and the study has three blind side. 3 General anesthesia. Intervention 1: Intervention group: The first intervention group(Tranexamic acid) receive 600mg oral Tranexamic acid and one placebo tablet 2 hour before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg). Intervention 2: Intervention group: The second intervention group(Clonidine) receive 0/2 mg tablet of Clonidine and 2 Capsules of placebo 2 hours before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg). Intervention 3: Control group: The second intervention group(Placebo) receive one tablet of Placebo and 2 Capsules of placebo 2 hours before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg). 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 further Information is available
public Mehrdad Masoudifar
Alzahra Hospital, Sofe Blvd, Shahid Keshvari highway
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Masoudifar
Alzahra hospital, Sofe Blvd, Shahid Keshvari highway
Isfahan Iran (Islamic Republic of) 8174675731 0098 31 362020202 Masoudifar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 20 – 65 year patients who consent to the informed consent to participate in the study ASA class 1 ,2 20 years 65 years Both Beta blocker and Calcium blocker usage sedative drugs usage Opioids usage addiction to Alcohol allergic reaction to drugs allergic reaction to Local anesthetic drugs history of lumbar surgery risk factor of thrombosis anticoagulants drugs usage Digoxin usage Aspirin uage M51.06 Intervertebral disc disorders with myelopathy, lumbar region Treatment - Drugs Treatment - Drugs Placebo Intervention group: The first intervention group(Tranexamic acid) receive 600mg oral Tranexamic acid and one placebo tablet 2 hour before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg) Intervention group: The second intervention group(Clonidine) receive 0/2 mg tablet of Clonidine and 2 Capsules of placebo 2 hours before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg) Control group: The second intervention group(Placebo) receive one tablet of Placebo and 2 Capsules of placebo 2 hours before surgery. Induction of anesthesia with 0/05mg/kg Midazolam, 3 microgram/Kg Fentanil, 2 mg/kg Propofol, 2mg/kg Lidocaine,Cisatracuriom 0/15 mg/kg and maintenance of anesthesia during the surgery is with 100microgram/kg/min Propofol and for induced of controlled hypotension infusion of 0/1-1 microgram/kg/min by goal of MAP(80-85mmHg) Systolic Blood Pressure. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: mmHg , SAADAT Sphygmomanometer monitoring. Diastolic Blood Pressure. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: mmHg , SAADAT Sphygmomanometer monitoring. Mean Artherial Pressure. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: mmHg , SAADAT Sphygmomanometer monitoring. Heart rate. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: beat/min , SAADAT ECG monitoring. Volume Of Blood Loss. Timepoint: enter to the recovery, export from recovery. Method of measurement: Milliliter,volume of blood in the suction, Bloody gas. Surgeon Satisfaction. Timepoint: End of the surgery. Method of measurement: Likert Scale. Hypotension. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: mmHg, SAADAT Sphygmomanometer monitor. Hypertension. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: mmHg, SAADAT Sphygmomanometer monitor. Tachycardia. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: beat/min ,SAADAT ECG monitoring. Bradycardia. Timepoint: Basic time(two hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, every 15 min during surgery, in the time of patient enter to the recovery. Method of measurement: beat/min ,SAADAT ECG monitoring. Esfahan University of Medical Sciences Approved 2020-06-22 Ethics committee of Isfahan University of Medical sciences Isfahan University Of Medical Science, Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)