The effect of ondansetron on reduction of etomidate-induced myoclonic movements in patients with ophthalmic surgery

The effect of ondansetron on myoclonic reduction induced by Etomidate

Clinical trial with control group, with parallel groups, randomized, phase 3 on 60 patients. The block method is used for randomization.

The study included 60 adult patients (over 18 years old) who are candidates for elective ophthalmic surgery with ASA I-II who are under general anesthesia for elective ophthalmic surgery in Mshhad Khatam Hospital. Patients entered the study after obtaining informed consent and explaining the study. Sampling method is available sampling method. Patients are treated with 5cc/kg fluid for 10minutes before induction and routine monitoring includes pulse Oximetry,ECG,NIBP and capnography are performed for patients. Patients with random allocation (block method) in 2 groups receiving ondansetron (4mg (IV) (group O) or control group with 5cc of N/S (IV) before They receive from Etomidate, are placed and receive this drug as a prodrug 180 seconds before induction with Etomidate at the rate of 0.3 mg/kg. The incidence of myoclonus is assessed by resident of anesthesia who is not aware of the groups,(triple blind) and the severity of myoclonus with a score between 0 and 3 are measured.

Inclusion criteria: Adults (over 18 years old) ASAІІ-І who are candidates for elective ophthalmic surgery. And consent to participate in the study. Exclusion criteria: 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

Patients with randomized allocation (block method) are divided into 2 groups receiving ondansetron (4 mg (IV) (group O) or the control group receiving 5cc of normal saline (IV) before Etomidate

Incidence and Intensity of myoclonic movements

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.

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.