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IRCT20160307026950N37 IRCT 2021-10-16 Esfahan University of Medical Sciences Effectiveness of two compounds Propofol - Sodium thiopental and Propofol - Etomidate in Cataract surgery Comparison of the effectiveness of two compounds Propofol - Sodium thiopental and Propofol - Etomidate on the quality of sedation and hemodynamic changes in Cataract surgery 2021-10-23 anticipated 64 Complete https://irct.ir/trial/59168 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: This is a simple randomized clinical trial in which individuals enter study groups by lottery; The drugs are placed in the desired number in sealed opaque and uniformly sealed bags. Each of the codes is also written on a piece of paper, folded and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box. Which is applied to the patient. This continues until the end of the paperwork so that the number of patients in the desired volume in the groups, Blinding description: This is a double-blind clinical trial; In this way, before obtaining consent, patients are studied but do not know which group they will be in and therefore are blind. Also, the nurse who injects the drug and the researcher who records the patient's symptoms do not know the type of drug and are blind. 3 Cataract. Intervention 1: Intervention group A: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, first receive 300 ml per hour of normal saline for preoperative fluid therapy, then they are given 1 mg per kg body weight of Propofol. (Diateb Company) - Sodium thiopental (Jaber Ibn Hayyan Company) is injected to induce anesthesia. The patient's clinical signs and hemodynamic changes are idolized at regular intervals until the end of recovery. Intervention 2: Intervention group B: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, first receive 300 ml per hour of normal saline for preoperative fluid therapy, then they are given 0.3 mg per kg body weight of Propofol. (Diateb Company) - Sodium thiopental (Jaber Ibn Hayyan Company) is injected to induce anesthesia. The patient's clinical signs and hemodynamic changes are idolized at regular intervals until the end of recovery. 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 Ali Aria
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 60 years Grade I, II and III in ASA criteria (American Society of Anesthesia) Candidate for Cataract surgery 18 years 60 years Both Patients with obstructive sleep apnea, mental disorder, autoimmune diseases, diabetes, nystagmus, leukemia, epilepsy and patients treated with psychiatric drugs Deafness Allergy to the drugs used Use of painkillers in the past week BMI (Body Mass Index) more than 35 H25 Age-related cataract Treatment - Drugs Treatment - Drugs Intervention group A: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, first receive 300 ml per hour of normal saline for preoperative fluid therapy, then they are given 1 mg per kg body weight of Propofol. (Diateb Company) - Sodium thiopental (Jaber Ibn Hayyan Company) is injected to induce anesthesia. The patient's clinical signs and hemodynamic changes are idolized at regular intervals until the end of recovery. Intervention group B: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, first receive 300 ml per hour of normal saline for preoperative fluid therapy, then they are given 0.3 mg per kg body weight of Propofol. (Diateb Company) - Sodium thiopental (Jaber Ibn Hayyan Company) is injected to induce anesthesia. The patient's clinical signs and hemodynamic changes are idolized at regular intervals until the end of recovery. Heart Rate. Timepoint: Before drug injection, 1 and 5 minutes after drug injection and then every 10 minutes until the end of recovery. Method of measurement: ECG monitoring. Sadation quality. Timepoint: Before drug injection, 1 and 5 minutes after drug injection and then every 10 minutes until the end of recovery. Method of measurement: RSS criteria (Ramsey sedation score). Mean arterial blood pressure. Timepoint: Before drug injection, 1 and 5 minutes after drug injection and then every 10 minutes until the end of recovery. Method of measurement: Barometer. Arterial blood oxygen saturation. Timepoint: Before drug injection, 1 and 5 minutes after drug injection and then every 10 minutes until the end of recovery. Method of measurement: Pulse oximeter. Rate of nausea and vomiting. Timepoint: Before drug injection, 1 and 5 minutes after drug injection and then every 10 minutes until the end of recovery. Method of measurement: Observation and asking. Duration of anesthesia. Timepoint: From the time the first sedation drug is administered until the effects of anesthesia are over. Method of measurement: o'clock. Duration of surgery. Timepoint: From the time the surgeon starts the cataract until the lens is done. Method of measurement: o'clock. Esfahan University of Medical Sciences Approved 2021-06-22 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)