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IRCT2015081723660N1 IRCT 2017-01-20 Hormozgan University of Medical Sciences Comparing the effect of lidocaine and magnesium sulfate combination with amiodarone and magnesium sulfate combination in preventing ventricular fibrillation heart rhythms after aortic artery occlusion clamp removal during the coronary artery graft surgery Comparing the effect of lidocaine- magnesium sulfate with amiodarone-magnesium sulfate in preventing ventricular fibrillation after aortic cross clamp removal in coronary artery graft surgery 2015-03-21 anticipated 70 Complete https://irct.ir/trial/20168 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 3 Ventricular fibrillation in coronary artery bypass graft operation. Intervention 1: All the patients received a standard monitoring, arterial and central venous catheter insertion. Premedication was applied by administering midazolam (0.05 mg/kg) with fentanyl (10 microgram/kg) and for anesthesia induction, etomidate (0.2 mg/kg), cis-atracurium (0.2 mg/kg) were administered, tracheal intubation and mechanical ventilation was established thereafter. Anesthesia was maintained by the infusion of sufentanil (0.01 microgram/kg/min), midazolam (1 mg/kg/min) and atracurium (8 microgram/kg/min). All the patients received a 30 mg/kg of sulphate magnesium through the bypass pump 10 minutes before the aortic cross clamp removal. The events recordings during anesthesia and drug administrations were performed by a qualified anesthesia technician who was not aware of the contents of the study syringes. Group A: Received the syringe pump A1 (10 cc of normal saline) 10 minutes before the opening of the aortic cross clamp and syringe pump A2 (2% lidocaine 1.5 mg/kg) 2 minutes before opening the aortic cross clamp were administered to the patients. Intervention 2: All the patients received a standard monitoring, arterial and central venous catheter insertion. Premedication was applied by administering midazolam (0.05 mg/kg) with fentanyl (10 microgram/kg) and for anesthesia induction, etomidate (0.2 mg/kg), cis-atracurium (0.2 mg/kg) were administered, tracheal intubation and mechanical ventilation was established thereafter. Anesthesia was maintained by the infusion of sufentanil (0.01 microgram/kg/min), midazolam (1 mg/kg/min) and atracurium (8 microgram/kg/min). All the patients received a 30 mg/kg of sulphate magnesium through the bypass pump 10 minutes before the aortic cross clamp removal. The events recordings during anesthesia and drug administrations were performed by a qualified anesthesia technician who was not aware of the contents of the study syringes. Group B: Received the syringe pump B1 (10 cc solution of 300 mg amiodarone and normal saline) 10 minutes before the opening of the aortic cross clamp and syringe pump B2 (5 cc of normal saline) 2 minutes before opening the aortic cross clamp were administered to the patients.
public Saeid Kashani
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 sdkashani@gmail.com Hormozgan University of Medical Sciences scientific Hashem Jarineshin
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 hjarineshin@yahoo.com Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical S Iran (Islamic Republic of) Inclusion criteria: ASA class 3-4, atherosclerosis vessel coronary-history with no previous cardiopulmonary resuscitation, patients with no medication of digoxin-amiodarone-lidocaine-magnesium Exclusion criteria: Concurrent other cardiac surgery, emergency surgery, allergy to drugs no limit no limit Both I49.0 Ventricular fibrillation and flutter Treatment - Drugs Treatment - Drugs All the patients received a standard monitoring, arterial and central venous catheter insertion. Premedication was applied by administering midazolam (0.05 mg/kg) with fentanyl (10 microgram/kg) and for anesthesia induction, etomidate (0.2 mg/kg), cis-atracurium (0.2 mg/kg) were administered, tracheal intubation and mechanical ventilation was established thereafter. Anesthesia was maintained by the infusion of sufentanil (0.01 microgram/kg/min), midazolam (1 mg/kg/min) and atracurium (8 microgram/kg/min). All the patients received a 30 mg/kg of sulphate magnesium through the bypass pump 10 minutes before the aortic cross clamp removal. The events recordings during anesthesia and drug administrations were performed by a qualified anesthesia technician who was not aware of the contents of the study syringes. Group A: Received the syringe pump A1 (10 cc of normal saline) 10 minutes before the opening of the aortic cross clamp and syringe pump A2 (2% lidocaine 1.5 mg/kg) 2 minutes before opening the aortic cross clamp were administered to the patients. All the patients received a standard monitoring, arterial and central venous catheter insertion. Premedication was applied by administering midazolam (0.05 mg/kg) with fentanyl (10 microgram/kg) and for anesthesia induction, etomidate (0.2 mg/kg), cis-atracurium (0.2 mg/kg) were administered, tracheal intubation and mechanical ventilation was established thereafter. Anesthesia was maintained by the infusion of sufentanil (0.01 microgram/kg/min), midazolam (1 mg/kg/min) and atracurium (8 microgram/kg/min). All the patients received a 30 mg/kg of sulphate magnesium through the bypass pump 10 minutes before the aortic cross clamp removal. The events recordings during anesthesia and drug administrations were performed by a qualified anesthesia technician who was not aware of the contents of the study syringes. Group B: Received the syringe pump B1 (10 cc solution of 300 mg amiodarone and normal saline) 10 minutes before the opening of the aortic cross clamp and syringe pump B2 (5 cc of normal saline) 2 minutes before opening the aortic cross clamp were administered to the patients. Ventricular fibrillation. Timepoint: 15 minute before operation till 24 hours after operation in ICU. Method of measurement: Electrocardiography. Central venous pressure. Timepoint: 15 minutes after anesthesia induction and 15 minutes after starting cardiopulmonary bypass. Method of measurement: Central venous pressure transducer monitor. Mean arterial pressure. Timepoint: 15 minutes after anesthesia induction and 15 minutes after starting cardiopulmonary bypass. Method of measurement: Invasive arterial blood pressure monitor. Heart rate. Timepoint: 15 minutes after anesthesia induction and 15 minutes after starting cardiopulmonary bypass. Method of measurement: electrocardiography monitor. Arterial blood gases (pH, arterial partial pressure of oxygen, arterial partial pressure of carbon dioxide, bicarbonate concentration). Timepoint: At phases of (base line, heart arrest, patient warming, and pump separation). Method of measurement: Arterial catheter blood sampling. Plasma (Na-K) electrolytes. Timepoint: At phases of (base line, heart arrest, patient warming, and pump separation). Method of measurement: Arterial catheter blood sampling. Blood plasma glucose. Timepoint: At phases of (base line, heart arrest, patient warming, and pump separation). Method of measurement: Arterial catheter blood sampling. Complete blood count of plasma. Timepoint: At phases of (base line, heart arrest, patient warming, and pump separation). Method of measurement: Arterial catheter blood sampling. Hormozgan University of Medical Sciences Approved 2010-09-23 Deputy for Research, and Medical Ethics Committee of Hormozgan University of Medical Sciences Joomhoori Islami Blv., Shahid Mohammadi Hospital Bandar Abbas Iran (Islamic Republic of)