]>
IRCT20141009019470N103 IRCT 2020-12-23 Shiraz University of Medical Sciences Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgeryon Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgery 2021-02-18 anticipated 80 Complete https://irct.ir/trial/51083 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization is from https://www.sealedenvelope.com/. To prevent the last allocation from being revealed, 4, 6 and 8 random blocks will be used to assign individuals to groups. The dark secret envelopes arranged by the study-independent analyzer are returned to the preoperative area by a nurse who is out of the study, and the patient profile sheets are removed, Blinding description: The nurses involved in this study are unaware of the type of intervention. In addition, all patients and authors of this study are unaware of the awakening time, extubation time, variables measured in the recovery room and the order of intervention. 2-3 Femur Fracture. Intervention 1: Intervention group:In the dexmedetomidine group, after diluting the drug with normal saline in a 50 ml syringe, 1 μg / kg dexmedetomidine is injected within 15 minutes and after induction of anesthesia, 0.5 μg / kg is injected during surgery.In the dexmedetomidine group, patients receive a sublingual placebo for blinding 15 minutes before induction of anesthesia. Intervention 2: Intervention group:In the melatonin group, 9 mg of melatonin is given sublingually 15 minutes before induction of anesthesia. In the melatonin group, patients receive a normal saline infusion placed on a syringe pump to blind the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is Its against our policy.
public Reza Jouybar
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 joybarr@sums.ac.ir Shiraz University of Medical Sciences scientific Reza Jouybar
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 joybarr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 21 and 60 years ASA I ,II BMI 18-30 Elective tympanomastoidectomy 21 years 60 years Both Hypersensitivity to propofol, dexmedetomidine or melatonin Consumption of opium and psychotropic drugs Consumption of beta blocker History of liver, kidney and cardiovascular failure Vascular stroke Neurological diseases Diabetes Hypothyroidism Peripheral or central vascular diseases History of high blood pressure History of taking anticonvulsant drugs Pace maker Duration of operation more than 180 minutes M80.05 Age-related osteoporosis with current pathological fracture, femur Prevention Prevention Intervention group:In the dexmedetomidine group, after diluting the drug with normal saline in a 50 ml syringe, 1 μg / kg dexmedetomidine is injected within 15 minutes and after induction of anesthesia, 0.5 μg / kg is injected during surgery.In the dexmedetomidine group, patients receive a sublingual placebo for blinding 15 minutes before induction of anesthesia. Intervention group:In the melatonin group, 9 mg of melatonin is given sublingually 15 minutes before induction of anesthesia. In the melatonin group, patients receive a normal saline infusion placed on a syringe pump to blind the study. Sedation. Timepoint: After transfer to the recovery room. Method of measurement: Richmond test. Anxiety. Timepoint: The morning of the operation, before entering the operating room. In the recovery room and after full awakening in 30,60,90,120 minutes. Method of measurement: BECk Anxiety Assessment Test. Pain. Timepoint: Severity of pain after waking up in the recovery room at 30,60,90,120 minute. Method of measurement: Visual analog Scale. Nausea and Vomiting. Timepoint: After transferring patients to the recovery room. Method of measurement: PONV score: 0 = no emetic symptoms, 1 = nausea, 2 = vomiting. The duration of the end of surgery until the extubation. Timepoint: The interval from the end of surgery to the removal of the endotracheal tube. Method of measurement: Observation. Duration of recovery. Timepoint: Duration of stay in recovery. Method of measurement: Observation. The amount of bleeding. Timepoint: At the end of surgery. Method of measurement: Observation. Shiraz University of Medical Sciences Approved 2020-06-15 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)