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IRCT20160716028945N4 IRCT 2018-11-07 Esfahan University of Medical Sciences Comparison of the effect of Quetiapine and Alprazolam on insomnia after coronary artery bypass graft sugery Comparison of the effect of Quetiapine and Alprazolam on sleep in patients who complain of insomnia after CABG (coronary artery bypass graft) surgery 2017-04-21 anticipated 64 Complete https://irct.ir/trial/23371 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Drugs were packed in groups A and B. Drugs packs were delivered to the nurses of heart surgery ward. Group A drugs were prescribed for patients who were entered to ward at saturday, monday and wednesday. Group B drugs were prescribed for patients who are entered to ward at sunday, tuesday and thursday. So the physician (main researcher), nurses and patients dont know the type of drugs. The executive manager and the collector of information know type of patients drugs. 3 Insomnia. Intervention 1: Intervention group: 32 patients recieve half of TRANQOPINE 25mg tablet, every nights 30 minutes before sleep, from 3 days after surgery until 14 days after surgery. Intervention 2: Control group: 32 patients recieve a ALPRAZOLAM 0.5 mg tablet from abidi company, Every nights 30 minutes before sleep, From 3 days after surgery until 14 days after surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of secondary data analyze
public Amir Mirmohammadsadeghi
Chamran Hospital, Salman Farsi st.
Isfahan Iran (Islamic Republic of) 81661-73414 +98 31 3260 0961 am_sadeghi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Amir Mirmohammadsadeghi
Chamran Hospital, Salman Farsi st.
Isfahan Iran (Islamic Republic of) 81661-73414 +98 31 3260 0961 am_sadeghi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient should undergo CABG and complain of insomnia after surgery no limit no limit Both Unstable medical conditions History of psycological disease Dementia Acute narrow angle glaucoma Hypersensitivity to drug G47.09 Other insomnia Treatment - Drugs Treatment - Drugs Intervention group: 32 patients recieve half of TRANQOPINE 25mg tablet, every nights 30 minutes before sleep, from 3 days after surgery until 14 days after surgery. Control group: 32 patients recieve a ALPRAZOLAM 0.5 mg tablet from abidi company, Every nights 30 minutes before sleep, From 3 days after surgery until 14 days after surgery. Insomnia score according to (ISI) questionnaire. Timepoint: Three days after surgery(before intervention) and fourteen days after surgery. Method of measurement: (ISI) insomnia questionnaire. Esfahan University of Medical Sciences Approved 2017-02-01 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Science Isfahan Isfehan Iran (Islamic Republic of)