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IRCT20160307026950N38 IRCT 2021-10-25 Esfahan University of Medical Sciences The effect of Ondansetron on pain caused by Etomidate injection Comparison of the effects of preventive injection of 4 mg and 8 mg Ondansetron doses on pain caused by Etomidate injection in patients under general anesthesia 2021-10-23 anticipated 60 Complete https://irct.ir/trial/59163 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is a simple randomized clinical trial in which patients are entered the study groups by lottery; The medicines and placebo are placed in the sealed, opaque and similar form packets which are coded. Each code 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; The pocket with the same number is the intervention that will apply for him. This process continues till the number of patients will reach the desired one, 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 Pain caused by Etomidate. Intervention 1: Intervention group A: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of normal saline per hour, then they are injected with 4 mg of Ondansetron made by Exir Pharmaceutical Company in 2 minutes and 2 minutes later, they are induced under anesthesia with 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded. Intervention 2: Intervention group B: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of normal saline per hour, then they are injected with 8 mg of Ondansetron made by Exir Pharmaceutical Company in 2 minutes and 2 minutes later, they are induced under anesthesia with 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded. Intervention 3: Control group C: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of Normal Saline per hour, then they are injected with 4 ml of distilled water and 2 minutes later under anesthesia. With 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded. 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 Ruzbeh Akhavanfar
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 Roozbeh1372@gmail.com 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 and II in ASA criteria (American Society of Anesthesia) Candidate for general anesthesia with Etomidate 18 years 60 years Both Patients with Heart Disease Patients with Psychologic disease Allergic to drugs used in the study Taking sedatives or painkillers 24 hours before anesthesia Addiction to drugs Prevention Prevention Placebo Intervention group A: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of normal saline per hour, then they are injected with 4 mg of Ondansetron made by Exir Pharmaceutical Company in 2 minutes and 2 minutes later, they are induced under anesthesia with 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded. Intervention group B: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of normal saline per hour, then they are injected with 8 mg of Ondansetron made by Exir Pharmaceutical Company in 2 minutes and 2 minutes later, they are induced under anesthesia with 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded. Control group C: In this group, eligible patients, after being placed on a surgical bed and monitoring connection, receive 300 ml of Normal Saline per hour, then they are injected with 4 ml of distilled water and 2 minutes later under anesthesia. With 20 mg of Etomidate made by Abu Reihan company and the patient's clinical symptoms are recorded. The amount of pain caused by Etomidate injection. Timepoint: During the injection until 30 seconds. Method of measurement: Faces Pain Rating Scale (FPRS). Heart Rate. Timepoint: Before injection, immediately after injection, 5 and 10 minutes after Etomidate injection and then every 15 minutes until the end of the operation. Method of measurement: ECG monitoring. Moderate arterial blood pressure. Timepoint: Before injection, immediately after injection, 5 and 10 minutes after Etomidate injection and then every 15 minutes until the end of the operation. Method of measurement: Barometer. Arterial blood oxygen saturation. Timepoint: Before injection, immediately after injection, 5 and 10 minutes after Etomidate injection and then every 15 minutes until the end of the operation. Method of measurement: Pulse oximeter. Duration of anesthesia. Timepoint: From the beginning of anesthesia to the end of recovery. Method of measurement: Clock. Esfahan University of Medical Sciences Approved 2021-07-01 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)