]>
IRCT20180120038450N2 IRCT 2019-08-17 Kermanshah University of Medical Sciences Evaluation of the Effect of Fast-Dissolving Sublingual Films of ondansetron on the Control of Nausea and Vomiting after Eye Surgery Formulation of Fast-Dissolving Sublingual Films of ondansetron Succinate by Electrospinning method and physicochemical and clinical evaluation in eye surgery patients 2019-08-22 anticipated 120 Complete https://irct.ir/trial/40584 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple and the unit is individual. The random number table is used as a randomization tool. Creating a random sequence is based on a single sequence of random assignments. The encryption is also done using a random-coded encoded box, Blinding description: In this double-blind study, both participants and evaluators of the outcome were unaware of the allocation of study groups. That is, the drugs in each group are similar in appearance. 3 Patients candidate for eye surgery. Intervention 1: Intervention group: In this study, we use ondansetron, which is made as a sublingual film with polyvinyl alcohol and beta-cyclodextrin polymers. Films containing 4 mg ondansetron are given sublingually only once after surgery if nausea and vomiting occur. Intervention 2: Control group: Patients in the control group are given ondansetron sublingual tablets at a dose of 4 mg only once in case of nausea. The patient places the drug under his tongue. This form of medicine is produced by Pars Darou Company. 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 There is no more information.
public Shahla Mirzaeei
14, 11 Abkaei,Bargh, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714415153 +98 83 3824 0526 shahlamirzaeei@gmail.com Kermanshah University of Medical Sciences scientific Shahla Mirzaeei
14, 11 Abkaei,Bargh, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714415153 +98 83 3824 0526 shahlamirzaeei@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Signature of written consent for participation in the study Age between 20 and 50 years From the point of view of classification of physical condition the American Society of Anesthesiologists was in the 1st and 2nd position 20 years 50 years Both Pregnancy, breastfeeding Taking drugs with anti-nausea effect in 24 hours before surgery History of motion sickness The history of systemic diseases: heart, kidney, liver, lung, psychosis, diabetes Nausea and vomiting within 24 hours before of eye surgery Use of steroids 24 hours before surgery Treatment - Drugs Treatment - Drugs Intervention group: In this study, we use ondansetron, which is made as a sublingual film with polyvinyl alcohol and beta-cyclodextrin polymers. Films containing 4 mg ondansetron are given sublingually only once after surgery if nausea and vomiting occur. Control group: Patients in the control group are given ondansetron sublingual tablets at a dose of 4 mg only once in case of nausea. The patient places the drug under his tongue. This form of medicine is produced by Pars Darou Company. The amount of nausea and vomiting. Timepoint: Baseline (immediately after surgery and before drug administration) and 1, 2, 4, 6 hours after drug administration. Method of measurement: Questionnaire with visual analogue scale. Kermanshah University of Medical Sciences Approved 2019-04-23 Ethics committee of Kermanshah University of Medical Sciences and Health Services Shahid Beheshti Blvd.- Central Organization of Kermanshah University of Medical Sciences kermanshah Kermanshah Iran (Islamic Republic of)