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IRCT20200611047728N1 IRCT 2020-08-06 Esfahan University of Medical Sciences Investigation of the effect of modafinil in coronary artery bypass graft surgery Investigation of the effect of modafinil on respiratory and cerebral consequences after coronary artery bypass graft surgery 2020-06-30 anticipated 74 Complete https://irct.ir/trial/48930 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization: Simple randomization, randomization unit: individual, randomization tool: randomized number table. The couple numbers will be in the intervention group and the odd numbers will be in the control group, Blinding description: The control drug is similar in appearance to the modafinil drug and is given to the patient by a person who has no role in the test, and then the information is collected by the same person. 2-3 respiratory and cerebral outcomes. Intervention 1: Intervention Group: After induction of anesthesia and endotracheal intubation, surgery will begin and after isolation of the patient from cardiopulmonary pump, modafinil (the drug is produced by Sobhan Daru Company) will be given to the patient orally with nasogastric tube by a person who has no role in the test. On the second morning of hospitalization, 200 mg modafinil will be given to patients in the intervention group orally by a person who has no role in the test. Intervention 2: Control group: After induction of anesthesia and endotracheal intubation, surgery will begin and after isolation from cardiopulmonary pump, the patient will be given placebo randomly and individually to the control group orally with nasogastric tube by a person who has no role in the test. On the second morning of hospitalization, the second dose of placebo will be given to the patient in the control group orally by a person who has no role in the test. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The study has not yet ended
public Dr. Mojtaba Mansouri
Shahid Chamran Hospital, Bozorgmehr Bridge, third moshtagh Street
Isfahan Iran (Islamic Republic of) 8166173414 +98 31 3261 1400 Drmkrezaei_62@yahoo.com Esfahan University of Medical Sciences scientific Dr. Mojtaba Mansouri
Shahid Chamran Heart Hospital, Bozorgmehr Bridge, third moshtagh Street
Isfahan Iran (Islamic Republic of) 8166173414 +98 31 3261 1400 Drmkrezaei_62@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) patients with coronary artery bypass graft surgery patients with a cardiac ejection fraction of more than 40% 18 years 80 years Both Patients with hepatic function failure Patients with renal function failure Patients with irregular cardiac primary rhythms Patients with cardiomegaly patients who have drug addiction patients who have alcoholism patients who are using psychiatric drugs J96.92, F1 Respiratory failure, unspecified with hypercapnia, Sedative, hypnotic or anxiolytic use, unspecified with sedative, hypnotic or anxiolytic-induced sleep disorder Treatment - Drugs Treatment - Drugs Intervention Group: After induction of anesthesia and endotracheal intubation, surgery will begin and after isolation of the patient from cardiopulmonary pump, modafinil (the drug is produced by Sobhan Daru Company) will be given to the patient orally with nasogastric tube by a person who has no role in the test. On the second morning of hospitalization, 200 mg modafinil will be given to patients in the intervention group orally by a person who has no role in the test. Control group: After induction of anesthesia and endotracheal intubation, surgery will begin and after isolation from cardiopulmonary pump, the patient will be given placebo randomly and individually to the control group orally with nasogastric tube by a person who has no role in the test. On the second morning of hospitalization, the second dose of placebo will be given to the patient in the control group orally by a person who has no role in the test. The time to reach full consciousness. Timepoint: Every hour until you reach full consciousness. Method of measurement: Richmond-Agitation Scale. Duration of mechanical ventilation in the intensive care unit. Timepoint: Every hour until you reach full consciousness. Method of measurement: In minutes using time meter. Length of stay in Intensive Care Unit. Timepoint: Every day until discharge from Intensive Care Unit. Method of measurement: By day using Count days. Carbon dioxide arterial pressure. Timepoint: Every one hour. Method of measurement: Arterial blood samples based on mercury mm. Esfahan University of Medical Sciences Approved 2020-06-29 Ethics Committee of Isfahan University of Medical Sciences Hezarjerib St. Isfahan University of Medical Sciences, School of Medicine Isfahan Isfehan Iran (Islamic Republic of)