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IRCT20220316054311N1 IRCT 2022-03-24 Vice-Chancellery for Research Hormozgan University of Medical Sciences The effect of dexmedetomidine on hemodynamic changes in patients undergoing coronary artery bypass graft The effect of dexmedetomidine on hemodynamic changes in patients undergoing coronary artery bypass graft 2021-12-22 anticipated 72 Complete https://irct.ir/trial/62569 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with individuals as units of randomization along with allocation concealment: 72 unclear envelopes and 72 cards with the names of the groups (A, B) will be prepared (36 cards for each group). The cards will be put into the envelopes and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled and one will randomly be selected. The patient will be allocated to group A or B based on the card inside the selected envelope. 3 coronary artery bypass graft. Intervention 1: Intervention group: In the dexmedetomidine group, one dose of the drug at 0.5 mcg/kg will be injected intravenously within 10 min. Intervention 2: Control group: They will receive no dexmedetomidine. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Seyed Mohammad Abtahi
Jomhouri Eslami Blvd., Payambar Azam Hospital
Bandar Abbas Iran (Islamic Republic of) 9791991551 +98 76 3334 5009 abtahi_mohamad@yahoo.com Bandare-abbas University of Medical Sciences scientific Seyed Mohammad Abtahi
Jomhouri Eslami Blvd., Payambar Azam Hospital
Bandar Abbas Iran (Islamic Republic of) 9791991551 +98 76 3334 5009 abtahi_mohamad@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age 30-80 years American Society of Anesthesiologists (ASA) class II, III, and IV Candidates of elective coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) 30 years 80 years Both Emergency surgery Ejection fraction <30% Concurrent valvular sugery Any complication during surgery and pacemaker requirement I25.709 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris Treatment - Drugs Other Intervention group: In the dexmedetomidine group, one dose of the drug at 0.5 mcg/kg will be injected intravenously within 10 min. Control group: They will receive no dexmedetomidine. Blood pressure. Timepoint: Baseline, before sternotomy, immediately after sternotomy and then at 10, 20, 30, 40, 50, and 60 min, before CPB, before cross clamp removal, before weaning, after weaning, before sternal closure, after sternal closure, at 1, 2, 3, 4, 5, and 6 hour in the intensive care unit. Method of measurement: Monitoring device. Mean arterial pressure. Timepoint: Baseline, before sternotomy, immediately after sternotomy and then at 10, 20, 30, 40, 50, and 60 min, before CPB, before cross clamp removal, before weaning, after weaning, before sternal closure, after sternal closure, at 1, 2, 3, 4, 5, and 6 hour in the intensive care unit. Method of measurement: Monitoring device. Systemic vascular resistance. Timepoint: Baseline, before sternotomy, immediately after sternotomy and then at 10, 20, 30, 40, 50, and 60 min, before CPB, before cross clamp removal, before weaning, after weaning, before sternal closure, after sternal closure, at 1, 2, 3, 4, 5, and 6 hour in the intensive care unit. Method of measurement: Monitoring device. Cardiac output. Timepoint: Baseline, before sternotomy, immediately after sternotomy and then at 10, 20, 30, 40, 50, and 60 min, before CPB, before cross clamp removal, before weaning, after weaning, before sternal closure, after sternal closure, at 1, 2, 3, 4, 5, and 6 hour in the intensive care unit. Method of measurement: Monitoring device. Heart rate. Timepoint: Baseline, before sternotomy, immediately after sternotomy and then at 10, 20, 30, 40, 50, and 60 min, before CPB, before cross clamp removal, before weaning, after weaning, before sternal closure, after sternal closure, at 1, 2, 3, 4, 5, and 6 hour in the intensive care unit. Method of measurement: Monitoring device. Central venous pressure. Timepoint: Baseline, before sternotomy, immediately after sternotomy and then at 10, 20, 30, 40, 50, and 60 min, before CPB, before cross clamp removal, before weaning, after weaning, before sternal closure, after sternal closure, at 1, 2, 3, 4, 5, and 6 hour in the intensive care unit. Method of measurement: Monitoring device. Cross clamp time. Timepoint: During surgery. Method of measurement: Clinical assessment. Pump time. Timepoint: During surgery. Method of measurement: Clinical assessment. Inotrope requirement. Timepoint: During surgery. Method of measurement: Clinical assessment. Vice-Chancellery for Research Hormozgan University of Medical Sciences Approved 2021-07-05 Ethics Committee of Hormozgan University of Medical Sciences Imam Hossein Blvd., across from Kargaran Sports Complex, Faculty of Medicine Bandar Abbas Hormozgan Iran (Islamic Republic of)