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IRCT20221126056613N5 IRCT 2023-08-27 Oroumia University of Medical Sciences Comparison of the effect of ketamine with fentanyl in control of acute pain after surgery Comparison of the effect of perioperative intravenous ketamine with fentanyl in control of acute pain after inguinal hernia repair surgery 2023-04-21 anticipated 60 Complete https://irct.ir/trial/69472 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to two ketamine and fentanyl (control) groups using Random Allocation computer software. In this way, numbers are given to the patients according to the determined sample volume, and then the software allocates the patients to two ketamine and fentanyl (control) groups based on the given numbers, Blinding description: After introducing the study to the patients and explaining the benefits and harms of the possible intervention, written consent is obtained from the patients. Then the patients are randomly assigned to one of the intervention or control groups. Patients and nurses who take care of the patients during the trial are blinded to the intervention and control groups, so that none of the nurses and patients know which drug, ketamine or fentanyl, the patients have been under general anesthesia with. 3 inguinal hernia. Intervention 1: Intervention group: In ketamine group, Induction of anesthesia is done with 1 to 4 mg/kg of intravenous ketamine, and then in maintenance phase, intravenous perfusion of ketamine at a rate of 2 to 10 μg/kg/min will be prescribed. Intervention 2: Control group: In fentanyl group, induction of anesthesia is performed with 1-2 μg/kg fentanyl as a routine anesthetic drug, and then maintenance phase, continuous infusion of fentanyl at a rate of 1-2 μg/kg/hr will be prescribed. 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 According to the results of the study, I will decide to publish
public Ali Akbar Nasir
Imam Khomeini Educational and Medical Center, Ershad St., Modares Blvd., Urmia
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3345 7286 Nasiriali7@gmail.com Oroumia University of Medical Sciences scientific Ali Akbar Nasiri
Imam Khomeini Educational and Medical Center, Ershad St., Modares Blvd., Urmia
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3345 7286 Nasiriali7@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 30-60 aged adults with inguinal hernia Absence of contraindications for ketamine and opioids use patients with American Society of Anesthesiologist (ASA) physical status I,II 30 years 60 years Both History of allergic reactions to the drug under study History of underlying diseases (diabetes, peptic ulcer, gastritis, coronary artery disease, renal failure) Any known psychiatric disorder Patients with incarcerated hernia patients with severe infection K40.9 Unilateral or unspecified inguinal hernia, without obstruction or gangrene Treatment - Drugs Treatment - Drugs Intervention group: In ketamine group, Induction of anesthesia is done with 1 to 4 mg/kg of intravenous ketamine, and then in maintenance phase, intravenous perfusion of ketamine at a rate of 2 to 10 μg/kg/min will be prescribed. Control group: In fentanyl group, induction of anesthesia is performed with 1-2 μg/kg fentanyl as a routine anesthetic drug, and then maintenance phase, continuous infusion of fentanyl at a rate of 1-2 μg/kg/hr will be prescribed. Intensity of pain. Timepoint: At 60, 90 minutes and 24 hours after surgery. Method of measurement: Based on numeric rating scale (NRS). The consumption of opioids for pain after surgery. Timepoint: Up to 24 hours after the surgery. Method of measurement: Based on milligrams. Oroumia University of Medical Sciences Approved 2023-04-19 Ethics committee of urmia University of Medical Sciences West Azarbaijan University of Medical Sciences, Resalat Blvd, urmia urmia West Azarbaijan Iran (Islamic Republic of)