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IRCT20201207049639N9 IRCT 2023-06-12 Oroumia University of Medical Sciences Investigating the effect of propofol, ketamine and ketofol on agitation after herniorrhaphy Comparison of the effects of propofol, ketamine, and ketofol on controlling agitation in children after herniorrhaphy 2023-07-23 anticipated 105 Complete https://irct.ir/trial/70595 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Patients will be divided into interventions groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention groups based on generated numbers, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the primary researcher who will assess the outcomes will be blind of the patient's allocation into one of the intervention groups. The syringes containing drugs will be similar in shape and size and the drug will be prescribed by an anesthesiologist (other than the outcome assessor). Therefore, the physician will be given a list of numbers generated by computer software, and the physician will assign patients to groups based on the order of the numbers, and finally, the groups will be labeled with letters A, B, and C. 3 Agitation after surgery. Intervention 1: Intervention group: For patients in group one, after induction of general anesthesia with sevoflurane, propofol 0.5 mg/kg will be injected intravenously. Intervention 2: Intervention group: For patients in group two after induction of general anesthesia with sevoflurane, Ketamine 0.5 mg/kg will be injected intravenously. Intervention 3: Intervention group: For patients in group three after induction of general anesthesia with sevoflurane, Ketofol 0.5 mg/kg will be injected intravenously. Yes - There is a plan to make this available What will be shared: Information can be provided without patients' names When: After the article is published To whom: Researchers Conditions: Only for research purposes Where to obtain: Email to the corresponding author: hooshyar.h@umsu.ac.ir How to obtain: Email to the corresponding author: hooshyar.h@umsu.ac.ir Comments:
public Dr. Hadi Hooshyar
Shahid Motahhari Hospital; Kashani street; Urmia; Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3193 8293 hooshyar.h@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Hadi Hooshyar
Shahid Motahhari Hospital; Kashani street; Urmia; Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3198 8293 hooshyar.h@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Children undergoing herniorrhaphy under general anesthesia Aged between 2-4 years Patients with physical status classified as ASA II and ASA III according to the criteria of the American Anesthesia Association (ASA). 2 years 4 years Both Mental retardation Neurological diseases Anomaly of the upper airway History of asthma or other lung diseases Pulmonary infections in the last 4 weeks R45.1 Restlessness and agitation Treatment - Other Treatment - Other Treatment - Other Intervention group: For patients in group one, after induction of general anesthesia with sevoflurane, propofol 0.5 mg/kg will be injected intravenously. Intervention group: For patients in group two after induction of general anesthesia with sevoflurane, Ketamine 0.5 mg/kg will be injected intravenously. Intervention group: For patients in group three after induction of general anesthesia with sevoflurane, Ketofol 0.5 mg/kg will be injected intravenously. Agitation score. Timepoint: After extubation, the time to leave the operating room, recovery and 30 minutes after surgery. Method of measurement: Four-point scale for assessing of agitation. Pain severity. Timepoint: Recovery, 30 minutes after surgery. Method of measurement: Consolability cry activity leg face (FLACC ). Heart rate. Timepoint: Every 15 minutes to one hour, and at hours 6, 12, and 24 after surgery. Method of measurement: Pulse oximetry. Vomiting. Timepoint: Within 24 hours after surgery. Method of measurement: Clinical examination. Oroumia University of Medical Sciences Approved 2023-03-08 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)