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IRCT20121204011662N14 IRCT 2020-03-28 Shiraz University of Medical Sciences Comparison the effects of two anesthetic drugs on agitation of children after anesthesia. Comparison the effects of Dexmedetomidine and remifentanil on emergence of agitation in children with sevoflurane anesthesia 2020-04-20 anticipated 90 Complete https://irct.ir/trial/46149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Patients will be randomly allocated into three groups by block randomization. In this technique, permutation block of size 6 will be made for patients of three groups A, B & C. In each block equal numbers for three groups will be considered in alternative positions. Then 15 blocks of size 6 will be selected randomly and patients will be allocated randomly and equally into three groups according to these permutation block, Blinding description: For blindness, All of the drugs solution (dexmedetomidine, remifentanil and normal saline) of this study will be prepared in 10 ml syringes that are similar and equal in shape, by a nurse of anesthesia who is aware of patients' grouping. These syringes will have label A , B or C. Anesthesiologist who will use these syringes will not aware of the content of these syringes, and just will use syringes with label A for patients in group A, syringes with label B for patients in group B and syringes with label C for patients in group C. Patients and all medical stuffs who will collaborate in data gathering, will not be aware of the content of these syringes. 3 Post operative agitation in children. Intervention 1: Intervention group 1: At the end of anesthesia, patients in group A will receive IV dexmedetomidine 0.1 mcg /Kg over five minutes with a 10 ml syringe with the label A. Intervention 2: Intervention group 2: At the end of anesthesia, patients in group B will receive IV infusion of remifentanyl 0.1 mcg/Kg over five minutes with a 10 ml syringe with the label B. Intervention 3: Control group: At the end of anesthesia, patients in group C will receive 10 ml of IV normal saline over five minutes with a 10 ml syringe with the label C. 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 further information.
public MohammadAli Sahmeddini
Anesthesia Department, Operation Room, Nemazee hospital, Nemazee square, Zand boulevard
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 sahmeddin@sums.ac.ir Shiraz University of Medical Sciences scientific MohammadAli Sahmeddini
Anesthesia and Critical Research Center, Anesthesia Department, Operation Room, Nemazee Hospital, Nemazee square
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 sahmeddini@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) All patients who will candidate for strabismus surgery under general anesthesia 2 years 7 years Both Patients with history of congenital heart disease Patients with history of renal disease Patients with history of liver disease Patients who needs rapid sequence induction Patients with history use of sedative drugs Patients with history of mental retardation Patients with history of psychiatric disorder Patients with history of allergy to drugs will be used in this study. R45.1 Restlessness and agitation Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: At the end of anesthesia, patients in group A will receive IV dexmedetomidine 0.1 mcg /Kg over five minutes with a 10 ml syringe with the label A. Intervention group 2: At the end of anesthesia, patients in group B will receive IV infusion of remifentanyl 0.1 mcg/Kg over five minutes with a 10 ml syringe with the label B. Control group: At the end of anesthesia, patients in group C will receive 10 ml of IV normal saline over five minutes with a 10 ml syringe with the label C. Postoperative agitation. Timepoint: At times: 0, 10 min, 20 min , 30 min after arrival in recovery room. Method of measurement: Pediatric anesthesia emergence delirium scale . Postoperative pain severity. Timepoint: At times: 0, 10 min, 20 min , 30 min after arrival in recovery room. Method of measurement: Children and infants postoperative pain scale. Mean arterial blood pressure (MAP). Timepoint: Preoperative, Intraoperative, Postoperative. Method of measurement: Non invasive blood pressure monitoring by digital blood pressure measuring of monitoring system. Heart rate per minute. Timepoint: Preoperative, Intraoperative, Postoperative. Method of measurement: Electrocardiogram. Satisfaction of the recovery room stuff from children condition. Timepoint: At the end of recovery stay. Method of measurement: Patient's files and records. Shiraz University of Medical Sciences Approved 2020-02-24 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)