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IRCT20190618043934N12 IRCT 2021-07-11 Birjand University of Medical Sciences Effects of propofol and ketofol on transient agitation induced by adenotonsillectomy Comparison of the effects of ketofol (Ketamine-Propofol mixture) with propofol on Transient agitation in children undergoing Adenotonsillectomy 2021-04-04 anticipated 32 Complete https://irct.ir/trial/55196 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be randomly divided into two groups after intervention with two drugs called ketofol (A) or propofol (B) using the block randomization process. Firstly, various quadruple blocks are created using a sealed envelope (AABB, BBAA, ABAB, BABA, ABBA, and BABA). One of these blocks is selected randomly and according to the order mentioned in the selected block, patients will be divided into one of two groups , namely A or B. Then randomization would be performed for other patients in the similar way, Blinding description: Outcome evaluator=the nurse who was not informed of the type of medication received by the children, performed the necessary evaluation 15 and 30 minutes after the surgery in the recovery room as well as 2,4 and 6 hours post surgery evaluation which were done in the ward. Then, the evaluation data will be submitted to the specific checklist designed for this purpose. The children participating in the study, are not informed of the anesthetic agents that were given to them. Because they are not conscious while going under anesthesia and their lack of information about these kinds of anesthetic agents. The analyst= the analyst does not have any information about the placement of people in the study and conducts analysis on data based on the codes defined by the study leader. 3 Tonsillitis. Intervention 1: Intervention group 1: The first group in the interventional study are patients who received propofol (made by Fresnius Kabi company in Germany) as a general intravenous anesthetic with the prescribed dose of 2 mg per kg for induction anesthesia as well as 0.5 mg/kg dosage of atracurium ampoule as a skeletal muscle relaxant before the surgery. Intervention 2: Intervention group 2: The second group in the interventional study are patients who are given ketofol in the ratio of 1 : 4 (40 mg ketamine made by Rotex Medica company in Germany + 160 mg propofol 1%) as a preoperative intravenous anesthetic agent for induction anesthesia as well as 0.5 mg/kg dosage of atracurium ampoule as a skeletal muscle relaxant before the surgery. 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 need to publish individual patient information
public Zabihullah Mohaghegh
No.56, Jorjani Ave, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717934888 +98 56 3232 3232 zabihullahmohaghegh@gmail.com Birjand University of Medical Sciences scientific Dr. Malihe Zangoee
Department of Anesthesiology, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717811674 +98 56 3232 3232 mzangoue@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Patients with ASA class one and two Age 3 to 9 years Without any addiction Without any requirements to prescribe any Narcotic drugs in recovery phase Without any known previous propofol allergy reactions 3 years 9 years Both Having mental and behavioral disorders Having a specific illness Cerebral trauma and bleeding or intracerebral mass Having congenital heart disease J03 Acute tonsillitis Treatment - Drugs Treatment - Drugs Intervention group 1: The first group in the interventional study are patients who received propofol (made by Fresnius Kabi company in Germany) as a general intravenous anesthetic with the prescribed dose of 2 mg per kg for induction anesthesia as well as 0.5 mg/kg dosage of atracurium ampoule as a skeletal muscle relaxant before the surgery. Intervention group 2: The second group in the interventional study are patients who are given ketofol in the ratio of 1 : 4 (40 mg ketamine made by Rotex Medica company in Germany + 160 mg propofol 1%) as a preoperative intravenous anesthetic agent for induction anesthesia as well as 0.5 mg/kg dosage of atracurium ampoule as a skeletal muscle relaxant before the surgery. Agitation. Timepoint: 15, 30 minutes after being in the recovery room and 2, 4 and 6 hours after surgery in the ward. Method of measurement: Using the Modified objective pain score criterion (MOPS). Birjand University of Medical Sciences Approved 2021-03-01 Ethics Committee of Birjand University of Medical Sciences Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town Birjand South Khorasan Iran (Islamic Republic of)