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IRCT2016081619470N40 IRCT 2017-04-19 Vice Chancellor for Research, Shiraz University of Medical Sciences Influence of Dexmedetomidine on Pulmonary Hypertensive Crisis and Arrhythmias and Extubation Time in Cardiac Surgery Patients with Left to Right Shunt and Severe PH Influence of Dexmedetomidine on Pulmonary Hypertensive Crisis and Arrhythmias and Extubation Time in Cardiac Surgery Patients with Left to Right Shunt and Severe PH 2017-04-21 anticipated 66 Complete https://irct.ir/trial/17413 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2-3 Congenital heart disease. Intervention 1: In dexmedetomidine group apart from common drugs used to manage anesthesia and pulmonary hypertension in patients with severe pulmonary hypertension like Milrinone and Sildenafil, dexmedetomidine began to be used in intravenous infusion with the dose of 0.5 5µg/kg/hr. from the beginning of cardiopulmonary bypass and continued for 24 hours. Intervention 2: In the control group apart from common drugs used to manage anesthesia and pulmonary hypertension in patients with severe pulmonary hypertension like Milrinone and Sildenafil, Dexmedetomidine was not used in intravenous infusion.
public Bahador Azizi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) +98 71 3647 4270 bahadorazizi@gmail.com Shiraz University of Medical Sciences scientific Dr Bahram Ghasemzadeh
Namazi Hospital, Namazi square
Shiraz Iran (Islamic Republic of) +98 71 3626 8088 ghasemzadeh@sums.ac.ir Shiraz Universiy of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: All children under one year old undergoing elective surgery and have severe pulmonary hypertension and left to right shunt. Exclusion criteria: severe hepatic failure, renal failure (Cr ≥1 / 5); heart block; primary hypotension, bradycardia. no limit 1 year Both Q24 Other congenital malformations of heart Treatment - Drugs Placebo In dexmedetomidine group apart from common drugs used to manage anesthesia and pulmonary hypertension in patients with severe pulmonary hypertension like Milrinone and Sildenafil, dexmedetomidine began to be used in intravenous infusion with the dose of 0.5 5µg/kg/hr. from the beginning of cardiopulmonary bypass and continued for 24 hours. In the control group apart from common drugs used to manage anesthesia and pulmonary hypertension in patients with severe pulmonary hypertension like Milrinone and Sildenafil, Dexmedetomidine was not used in intravenous infusion. Arrhythmias. Timepoint: At 0,6,12, 24, 48, 72hours during surgery and after surgery in the ICU. Method of measurement: EKG monitoring. Pulmonary artery pressure. Timepoint: After surgery and after pulmonary artery catheter insertion in the intensive care unit. Method of measurement: pulmonary artery catheter. Patient's extubation time. Timepoint: After transferring patient to the intensive care unit. Method of measurement: observasion. Vice Chancellor for Research, Shiraz University of Medical Sciences Approved 2014-08-20 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 Iran (Islamic Republic of)