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IRCT20200306046706N1 IRCT 2020-04-16 Yazd University of Medical Sciences Effect of Gabapentin on prevention of Delirium The effect of Gabapentin on prevention of delirium in patients undergoing coronary artery bypass graft surgery 2018-09-23 anticipated 60 Complete https://irct.ir/trial/46365 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using a Random Number Table,Individuals in two groups A and B were included in the study, Blinding description: Participant: After giving informed consent, they entered the intervention groups. Investigator:Not knowing which group A and B are medication and placebo . Physician and nurse: Not knowing which group A and B are medication and placebo . Outcome assessor:Not knowing which group A and B are medication and placebo . Data analyzer:Not knowing which group A and B are medication and placebo . 3 Coronary Heart Disease, Delirium, Open Coronary Heart Surgery. Intervention 1: Intervention group: Gabapentin 400 mg capsule, daily, for three days, with sufficient water in the morning, prepared by the Pharmacology Group. Intervention 2: Control group: Multivitamin Capsule, daily, for three days, in the morning with sufficient amount of water, prepared by Pharmacology Group. 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 No more information
public Elham Farzannejad
Second Kui, Shahid Ashtarzade Alley, Maskan Street, Kashani Ave
Yazd Iran (Islamic Republic of) 8915664167 +98 35 3623 7273 elhamfarzannejad@yahoo.com Yazd University of Medical Sciences scientific Elham Farzannejad
Second Kui, Shahid Ashtarzade Alley, Maskan Street, Kashani Ave
Yazd Iran (Islamic Republic of) 8915664167 +98 35 3623 7273 elhamfarzannejad@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) All patients undergoing Coronary Artery Bypass Graft Surgery 45 years no limit Both History of taking anticonvulsants, History of Gabapentin drugs consumption in the last two weeks History of proven psychological problems Emergency surgery ICU Admision before surgeon Delirium before surgery History of previous cardiac surgery F05 Delirium due to known physiological condition Prevention Placebo Intervention group: Gabapentin 400 mg capsule, daily, for three days, with sufficient water in the morning, prepared by the Pharmacology Group. Control group: Multivitamin Capsule, daily, for three days, in the morning with sufficient amount of water, prepared by Pharmacology Group Permitted delirium according to the CAM-IC criteria. Timepoint: Examine delirium twice daily, days 1, 2, 3. Method of measurement: Confusion Assessment Method-ICU. Postoperative mortality. Timepoint: Death occurring from 36 hours to one month after surgery. Method of measurement: Phone Follow up. Yazd University of Medical Sciences Approved 2019-02-05 Ethics Committee of Yazd University of Medical Sciences Second Kui, Shahid Ashtarzadeh Alley, Maskan Street, Kashani Ave Yazd Yazd Iran (Islamic Republic of)