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IRCT20200325046853N1 IRCT 2020-04-12 Esfahan University of Medical Sciences Survey of effect of Dexmedetomidine on children undergoing Adenotonslectomy ; Survey of effect of two single doses of bolus Dexmedetomidine (1 µg / kg and 2 µg / kg) on intraoperative hemodynamic status and agitation in the recovery of children undergoing Adenotonsillectomy; 2020-04-20 anticipated 105 Complete https://irct.ir/trial/46781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, 105 eligible patients are selected by simple random sampling, then to divide them into three groups, we use Random Allocation software, so that the code selected by this software for three groups of 35 people in 3 envelopes in packages A, B and C Each envelope will be assigned to one of the three groups by the person who is not involved in the process. For example, envelope A, which contains 35 random codes from 1001 to 1105, will be randomly assigned to one of the three intervention groups 1, or intervention 2, or control, and the syringes will be prepared according to the blinding conditions, Blinding description: To meet the double blindness of the study, doses of both micrograms per kg and one micrograms per kg diluted Dexmedetomidine in a volume of 10 cc are embedded in the syringes. The other syringe will be made without dexmedetomidine and contains only 10 cc Normal saline. The specialist in these syringes will label the A, B and C labels and will provide the researcher daily. Thus, until the data is collected by the nurse, the registrant will not know the type of medication in the syringes. the information analyst will have no knowledge of the types of groups. 3 Chronic tonsillitis and adenoiditis. Intervention 1: Intervention group : The first intervention group receives 1 micrograms per kilogram of dexmedetomidine manufactured by Elixir Company, which is diluted in a volume of 10 cc as a single dose and bolus and received within ten minutes. Dexmedetomidine with the formula C13H16N2 and with the brand name precedex is one of the Imidazole drugs that has Urinary excretion. It has a half-life of two to three hours and does not have active metabolites. It has a high protein binding (94%). This drug is a pure agonist or a complete alpha-2 receptor agonist. Various methods are used to maintain a stable hemodynamic status and reduce bleeding during surgery. On the other hand, prolonged surgery and instability of hemodynamics are associated with more complications of children's recovery Dexmedetomidine is a central alpha-2 adrenergic agonist that has both sedative and analgesic effects. The use of this drug in children has increased day by day due to its neuroprotective properties. According to the findings so far, dexmedetomidine is one of the few drugs that does not cause cognitive impairment in children after anesthesia. Intervention 2: Intervention group :The second intervention group receives 2 micrograms per kilogram of dexmedetomidine manufactured by Elixir Company, which is diluted in a volume of 10 cc as a single dose and bolus and received within ten minutes. Intervention 3: Control group: 10 cc normal saline. Yes - There is a plan to make this available What will be shared: If necessary, the data can be published without name and with all the details. When: 6 months after printing the results. To whom: Researchers working in popular scientific and academic centers who are employed and studying and have a relevant research in this field that needs my data to advance research. Conditions: If the data of this study is needed to progress and conduct a similar study. Where to obtain: The original authors of the study. How to obtain: The researcher emails a valid letter from his / her work or employment stating the reason for the need for the data and after reviewing it in the research department and after the agreement of the authors and financial support centers, the data and documents are provided to them. Comments:
public Hasti sadat Aledavood
No. 103, Alvand 2 Ave., Ghadir Blvd., Sepahanshahr Town
Esfahan Iran (Islamic Republic of) 8179914387 0098316515046 hasti.aledavood2@gmail.com Esfahan University of Medical Sciences scientific Hasti sadat Aledavood
No.103,Padideh Bluding, Alvand 2 Ave., Ghadir Blvd., Sepahan shahr Town
Esfahan Iran (Islamic Republic of) 8179914387 +98 31 3651 5046 hasti.aledavood2@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 3-10 year old childern candidates for adenotonsillectomy Children who fall into the ASAI, ASAII group in terms of physical condition to determine the risk of anesthesia Consent to participate in the study 3 years 10 years Both Includes any underlying disease (heart-lung disease, kidney, glands, etc.) Bleeding disorders Impaired coagulation tests (PT, PTT, INR) Metabolic disorders (phenylketonuria, galactasomy, etc.). J35.0 Chronic tonsillitis and adenoiditis Treatment - Drugs Treatment - Drugs Placebo Intervention group : The first intervention group receives 1 micrograms per kilogram of dexmedetomidine manufactured by Elixir Company, which is diluted in a volume of 10 cc as a single dose and bolus and received within ten minutes. Dexmedetomidine with the formula C13H16N2 and with the brand name precedex is one of the Imidazole drugs that has Urinary excretion. It has a half-life of two to three hours and does not have active metabolites. It has a high protein binding (94%). This drug is a pure agonist or a complete alpha-2 receptor agonist. Various methods are used to maintain a stable hemodynamic status and reduce bleeding during surgery. On the other hand, prolonged surgery and instability of hemodynamics are associated with more complications of children's recovery Dexmedetomidine is a central alpha-2 adrenergic agonist that has both sedative and analgesic effects. The use of this drug in children has increased day by day due to its neuroprotective properties. According to the findings so far, dexmedetomidine is one of the few drugs that does not cause cognitive impairment in children after anesthesia. Intervention group :The second intervention group receives 2 micrograms per kilogram of dexmedetomidine manufactured by Elixir Company, which is diluted in a volume of 10 cc as a single dose and bolus and received within ten minutes. Control group: 10 cc normal saline Agitation rate. Timepoint: Every 15 minutes in recovery. Method of measurement: Paediatric Anesthesia Emergence Delirium score. Sedation rate. Timepoint: Every 15 minutes in recovery. Method of measurement: Ramsay Sedation Scale score. Length of stay in recovery. Timepoint: Every 15 minutes in recovery. Method of measurement: Modified Aldrete Score. Spo2. Timepoint: Before and during anesthesia Every 15 minutes in recovery. Method of measurement: by Pulse oximetr. Blood pressure. Timepoint: Before and during anesthesia Every 15 minutes in recovery. Method of measurement: By manometer. Heart rate. Timepoint: Before and during anesthesia Every 15 minutes in recovery. Method of measurement: manually. Bleeding volume. Timepoint: During surgery. Method of measurement: In milliliter. Average dose of propofol for the treatment of delirium. Timepoint: During recovery. Method of measurement: milligram per kilogram. Esfahan University of Medical Sciences Approved 2020-03-17 Ethics committee of Isfahan University of Medical Sciences No.103, Padideh Bulding , Alvand 2 Ave., Ghadir Blvd.,Sepahan shar Esfahan Isfehan Iran (Islamic Republic of)