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IRCT20141009019470N76 IRCT 2018-09-06 Shiraz University of Medical Sciences Effect of modafinil for prevention of cognitive and sociological dysfunction after sleeve gastrectomy Effect of modafinil for prevention of cognitive and sociological dysfunction after sleeve gastrectomy 2018-09-01 anticipated 80 Complete https://irct.ir/trial/33495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomized according to the charts which was derived from www.randomization.com site, Blinding description: The investigator determines the type of drug or placebo based on the randomized list and provides drug or placebo to the nurse in the ward for prescribing to the patient. The patient and the person evaluating the patient after the surgery are unaware of the type of intervention. 2-3 sleeve gastrectomy. Intervention 1: Intervention group:patients received 2 tablets of modafinil 100 mg two hours before the operation. Intervention 2: Control group: patients received 2 tablets of placebo two hours before the operation. 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 Its against our policy.
public Kambiz Golestani
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 masihifarzaneh@yahoo.com Shiraz University of Medical Sciences scientific Mehrdad Salari
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 masihifarzaneh@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients who are candidate for elective sleeve gastrectomy ASA I-II age between 18-45 years old 18 years 45 years Both Active and uncontrolled diseases of the cardiovascular system. Gastrointestinal diseases. Liver disease. kidney Diseases. Psychological and mental illness. Neurological diseases. Taking psychiatric medications. opium addiction K95.89 Other complications of other bariatric procedure Prevention Placebo Intervention group:patients received 2 tablets of modafinil 100 mg two hours before the operation. Control group: patients received 2 tablets of placebo two hours before the operation. Depression and Anexiety. Timepoint: The day before the surgery and after leaving the recovery room. Method of measurement: Depression and Anxiety Scale, DASS-21. Cognitive problems. Timepoint: The day before the surgery and after leaving the recovery room. Method of measurement: The Addenbrooke's Cognitive Examination (ACE). Shiraz University of Medical Sciences Approved 2017-08-23 Ethics Committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)