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IRCT201611039014N130 IRCT 2016-11-05 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Evaluation of the sedative effect of sublingual lorazepam versus placebo in patients who are candidate for endoscopy Evaluation of the sedative effect of sublingual lorazepam versus placebo in patients who are candidate for endoscopy: a double blind randomized clinical trial 2016-11-21 anticipated 114 Complete https://irct.ir/trial/9568 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind. 2 candidate for endoscopy. Intervention 1: Intervention group: sublingual tablet lorazepam 2 mg single dose half hour before endoscopy. Intervention 2: Control group: placebo single dose half hour before endoscopy.
public Zohreh Seifi
Shahid Beheshti Hospital, Eram Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 0283 zseifi861372@gmail.com Shahid Beheshti Hospital scientific Dr Maryam Hasan Zarini
Shahid Beheshti Hospital, Eram Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 0283 mhzarrini@sums.ac.ir Shahid Beheshti Hospital Iran (Islamic Republic of) Inclusion criteria: candidate for endoscopy; age of 18 to 55 years. Exclusion criteria: cardiopulmonary disease; neuropsychological disorders; sensitivity to lorazepam; body mass index above 30. 18 years 55 years Both Y61.4 During endoscopic examination Treatment - Drugs Placebo Intervention group: sublingual tablet lorazepam 2 mg single dose half hour before endoscopy. Control group: placebo single dose half hour before endoscopy Sedative effect of drug. Timepoint: half hour after treatment. Method of measurement: through physical examination. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2016-10-29 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)