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IRCT20180922041084N5 IRCT 2022-01-05 Shiraz University of Medical Sciences The effects of dexmedetomidine on post-operative blood glucose level in non diabetic patients undergoing cardiac surgery The effects of dexmedetomidine on post-operative blood glucose level in non diabetic patients undergoing cardiac surgery 2021-09-12 anticipated 72 Complete https://irct.ir/trial/58696 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: change of blood glucose level during the surgery.The effects of dexmedetomidine on postoperative blood glucose level, measurement of potassium, blood pressure, and heart rate during surgery, Randomization description: In this study, we will use the limited randomization method of block randomization. The size of all blocks is equal and we will have 6 groups of 6 blocks (including 3 participants in the intervention group and 3 participants in the control group) in this two-group experiment. The randomization list is also taken from the random sequence generation site www.sealedenvelope.com, which is able to generate random sequences by blocking method, Blinding description: Medications in 50cc syringes are prepared by a nurse anesthetist (who is not involved in the rest of the sample collection process) and the anesthesiologist and nurse anesthetist and ICU nurse who is responsible for monitoring and sampling the patient is not aware of the type of medication prescribed. 3 Coronary Arteria Bypass Graft. Intervention 1: Intervention group: Intervention group or group (dexmedetomidine (D)): In this group, continuous injection of dexmedetomidine made by ExIR Company at a dose of 0.5 µ g / kg/hr. It is infused by a continuous infusion pump after induction of anesthesia. Intervention 2: Control group: (control (C)) in this group injection of normal saline 0.9% at a dose of 0.5 µ g / kg / hr. It will be infused by a continuous infusion pump after induction of anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy.
public Amirhosein Hasanzade
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3630 4312 A.hsanzade1367@gmail.com Shiraz University of Medical Sciences scientific Simin Azemati
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 azemati@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) The Patients are Candidates for Coronary Artery Surgery (CABG). No history of diabetes. The patients 40 to 80 years of age Receive informed written consent EF more than 40%. 40 years 80 years Both emergency surgery valvular heart disease liver and kidney dysfunction take steroids History of drug sensitivity heart failure Acute Myocardial Infarction Z95.1 Presence of aortocoronary bypass graft Treatment - Drugs Placebo Intervention group: Intervention group or group (dexmedetomidine (D)): In this group, continuous injection of dexmedetomidine made by ExIR Company at a dose of 0.5 µ g / kg/hr. It is infused by a continuous infusion pump after induction of anesthesia. Control group: (control (C)) in this group injection of normal saline 0.9% at a dose of 0.5 µ g / kg / hr. It will be infused by a continuous infusion pump after induction of anesthesia. Blood Glucose. Timepoint: Blood sugar before, during, and after surgery. Before induction of anesthesia, 15 minutes after induction of anesthesia, before the start of the cardiopulmonary pump, 30 minutes after the start of the cardiopulmonary pump, time of transfer to ICU 6 hours after transfer to ICU, 12 hours after transfer to ICU, and 24 hours after transfer to ICU. Method of measurement: Check Blood glucose by glucometer. Blood Potassium. Timepoint: Before induction of anesthesia (T0), 15 minutes after induction of anesthesia (T1), before the start of the cardiopulmonary pump (T2), 30 minutes after the start of the cardiopulmonary pump (T3), transfer time to ICU(T4), 6 hours after transfer to ICU (T5), 12 hours after transfer to ICU (T6), 24 hours after ICU transfer (T7). Method of measurement: By blood gas. Check Heart rate. Timepoint: Before induction of anesthesia (T0), 15 minutes after induction of anesthesia (T1), before the start of the cardiopulmonary pump (T2), 30 minutes after the start of the cardiopulmonary pump (T3), transfer time to ICU(T4), 6 hours after transfer to ICU (T5), 12 hours after transfer to ICU (T6), 24 hours after ICU transfer (T7). Method of measurement: By heart monitoring. Mean Arterial blood pressure. Timepoint: transfer time to ICU(T4), 6 hours after transfer to ICU (T5), 12 hours after transfer to ICU (T6), 24 hours after ICU transfer (T7). Method of measurement: Invasive arterial blood pressure monitoring. Shiraz University of Medical Sciences Approved 2020-05-20 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)