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IRCT20190510043545N2 IRCT 2021-10-02 Mashhad University of Medical Sciences The effect of ondansetron on reduction of etomidate-induced myoclonic movements The effect of ondansetron on reduction of etomidate-induced myoclonic movements in patients with ophthalmic surgery 2021-10-07 anticipated 60 Complete https://irct.ir/trial/58661 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be randomly divided into two groups using a random blocking method with a size of 4 blocks using Software Allocation Random (RAS) software with a 1: 1 allocation ratio by the non-involved person in the study. To conceal the allocation, closed opaque envelopes will be prepared and numbered according to the number of samples. Envelope preparation and random allocation sequencing will be performed by the non-research person, Blinding description: Participants are divided into two groups receiving normal saline (control group) and ondansetron (intervention group) as prodrug. The participant is injected intravenously and does not know which group he is in. The person assigning the samples to the groups does not know the assigned group. The person examining the incidence and severity of myoclonus is not aware of the participant's assigned group, and the analyzer is not aware of the assigned group. 3 etomidate-induced myoclonic movements. Intervention 1: The ondansetron group received 4 mg (IV) (group O) before Etomidate and received the drug as a prodrug 180 seconds before induction with Etomidate at a dose of 0.3 mg / kg.This drug is used as a single dose of 4 mg intravenously 180 seconds before Etomidate injection. Ondansetron is a serotonin antagonist. In all participants, the drug will be used by one company. Intervention 2: Control group: The control group received 5 cc of normal saline (IV) before Etomidate and received the drug as a prodrug 180 seconds before induction with Etomidate at the rate of 0.3 mg / kg.Normal saline will be injected as a placebo. 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 further information The Data of all participants will be published as general results of the study.
public Mohamad Alipour
Ahmad Abad Blvd , Mashhad , Iran
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 sjvdpurafzali@yahoo.com Mashhad University of Medical Sciences scientific Mohamad Alipour
Ahmad Abad Blvd , Mashhad , Iran
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 sjvdpurafzali@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Adults (over 18 years old) ASAІІ-І who are candidates for elective ophthalmic surgery. And consent to participate in the study. 18 years no limit Both Patients with adrenal dysfunction Drug allergy Mental disorders Neuromuscular disease Seizures Electrolyte disorders Surgery with a high risk of nausea and vomiting such as strabismus G25.3 Myoclonus Prevention Prevention The ondansetron group received 4 mg (IV) (group O) before Etomidate and received the drug as a prodrug 180 seconds before induction with Etomidate at a dose of 0.3 mg / kg.This drug is used as a single dose of 4 mg intravenously 180 seconds before Etomidate injection. Ondansetron is a serotonin antagonist. In all participants, the drug will be used by one company. Control group: The control group received 5 cc of normal saline (IV) before Etomidate and received the drug as a prodrug 180 seconds before induction with Etomidate at the rate of 0.3 mg / kg.Normal saline will be injected as a placebo. Intensity of myoclonus. Timepoint: The occurrence and severity of myoclonus are controlled from the time of injection to 90 seconds after atomiditis injection. Method of measurement: myoclonic movements score. Mashhad University of Medical Sciences Approved 2021-06-15 Ethics committee of Mashhad University of Medical Sciences Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)