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IRCT2017041712830N21 IRCT 2017-06-29 Vice chancellor for research of Bushehr University of Medical Sciences The effect of remote ischemic preconditioning in prevention of delirium in patient with cardiopulmonary bypass The effect of remote ischemic preconditioning in prevention of delirium in patient with cardiopulmonary bypass 2017-06-22 anticipated 80 Complete https://irct.ir/trial/12847 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Other design features: Randomization by using Excel table. N/A delirium. Intervention 1: Intervention group: A checklist that investigates the psychological status of patients will be filled the night before open heart surgery. The occurrence of delirium is investigated by questionnaire from the night before surgery daily until 5 days after the operation. Assessing delirium will be done in 18-20 pm. The type, dosage and time of using medication (for example haloperidol if necessary) will also be recorded in the questionnaire. In remote ischemic preconditioning technique, an inflated blood pressure cuff, 9-12 cm wide, will be used after induction of anesthesia which will be closed at the top of participants’arm. Pressure of cuff is 200 mm Hg. Duration of use of inflated cuff is five minutes and after that cuff will be emptied in five minutes. The intervention will be done in three five-minute cycles and totally takes 30 minutes. During the anesthesia induction phase, medications such as Etomidate, which cannot induce remote preconditioning ischemic condition, will be used . After ECG, SPO2 and arterial line monitoring, induction of anesthesia starts. The method of anesthesia induction is considered by medications including Etomidate + Sufentanil+Midazolam. After intubating and placing CVP, patients are maintained by removal of inhaled medications Isoflurane and Sevoflurane and application of infusion of Sufentanil + Midazolam+ Atracurium. All patients receive 100% oxygen during anesthesia step. In anesthesia, patients candidate for open heart surgery require embedded arterial line (mostly from the left hand which induces no cardiovascular problems) and intravenous lines are inserted in the other hand. Cuff will be closed on another hand. All intravenous lines will be taken in the same hand with arterial lines. This intervention will be done under supervision of heart anesthesiologist. Intervention 2: Control Group: In this group, alsothe questionnaire in the night before surgery and daily to 5 days after surgery would be filled. In this group, after induction of anesthetic, preconditioning Ischemic method wouldn’t be used. The method and the use of anesthetic drugs in this group is similar to intervention group.
public Dr Faezeh Jahanpour
School of Nursing and Midwifery, Bushehr University of Medical Sciences
Bushehr Iran (Islamic Republic of) +98 77 3332 8598 f.jahanpour@bpums.ac.irfa_jahanpour@yahoo.com Bushehr University of Medical Sciences scientific Dr Faezeh Jahanpour
School of Nursing and Midwifery, Bushehr University of Medical Sciences
Bushehr Iran (Islamic Republic of) +98 77 3332 8598 f.jahanpour@bpums.ac.ir fa_jahanpour@yahoo.com Bushehr University of Medical Sciences Iran (Islamic Republic of) Major inclusion criteria: candidates for elective cardiopulmonary bypass surgery; 55-70 years old patients؛ patients with EF greater than 35% (Severe LV dysfunction). Major exclusion criteria: Reexploration (Patients who return to operating room after heart surgery due to excessive bleeding)؛ embedded IABP (embedded balloon pump in the operating room or the ICU because of LV dysfunction؛ patients with acute MI (patients with myocardial infarction during previous week)؛ DM؛ history of stroke؛ upper extremity peripheral vascular problems؛ unwillingness to continue the participation, no initial consent؛ transfer to other medical centers؛ psychiatric drugs؛ history of psychiatric disorders such as psychosis, mental retardation؛ presence of ST changes during operation 55 years 70 years Both F05 Postoperative delirium Prevention Prevention Intervention group: A checklist that investigates the psychological status of patients will be filled the night before open heart surgery. The occurrence of delirium is investigated by questionnaire from the night before surgery daily until 5 days after the operation. Assessing delirium will be done in 18-20 pm. The type, dosage and time of using medication (for example haloperidol if necessary) will also be recorded in the questionnaire. In remote ischemic preconditioning technique, an inflated blood pressure cuff, 9-12 cm wide, will be used after induction of anesthesia which will be closed at the top of participants’arm. Pressure of cuff is 200 mm Hg. Duration of use of inflated cuff is five minutes and after that cuff will be emptied in five minutes. The intervention will be done in three five-minute cycles and totally takes 30 minutes. During the anesthesia induction phase, medications such as Etomidate, which cannot induce remote preconditioning ischemic condition, will be used . After ECG, SPO2 and arterial line monitoring, induction of anesthesia starts. The method of anesthesia induction is considered by medications including Etomidate + Sufentanil+Midazolam. After intubating and placing CVP, patients are maintained by removal of inhaled medications Isoflurane and Sevoflurane and application of infusion of Sufentanil + Midazolam+ Atracurium. All patients receive 100% oxygen during anesthesia step. In anesthesia, patients candidate for open heart surgery require embedded arterial line (mostly from the left hand which induces no cardiovascular problems) and intravenous lines are inserted in the other hand. Cuff will be closed on another hand. All intravenous lines will be taken in the same hand with arterial lines. This intervention will be done under supervision of heart anesthesiologist. Control Group: In this group, alsothe questionnaire in the night before surgery and daily to 5 days after surgery would be filled. In this group, after induction of anesthetic, preconditioning Ischemic method wouldn’t be used. The method and the use of anesthetic drugs in this group is similar to intervention group. Delirium. Timepoint: Before the intervention, one to five days after the intervention. Method of measurement: The checklist of delirium(NEECHAM). Vice chancellor for research of Bushehr University of Medical Sciences Approved 2017-03-13 Ethics committee of Bushehr University of Medical Sciences Bushehr University Of Medical Sciences, Next to the hospital Salman Farsi, Sabzabad,Bushehr Bushehr Iran (Islamic Republic of)