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IRCT20181130041804N1 IRCT 2019-01-23 Sanandaj University of Medical Sciences Effect of two drugs, propofol and fentanyl in controlling emergence agitation following anesthesia with sevoflurane gas Comparison the effect of two drugs, propofol and fentanyl in controlling emergence agitation of 2 to10 years old children following general anesthesia with sevoflurane 2018-12-31 anticipated 50 Complete https://irct.ir/trial/35665 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random allocation is permuted block randomization using following pattern. Group A: Propophol drug Group B: Fentanyl drug BABA ABBA BBAA AABB BABA ABAB BAAB ABBA In the first 4 patients, the first and third persons recieve fentanyl and the second and fourth patients recieve propofol. In the next four, the first two recieve fentanyl drugs and the third and fourth patients recieve the drug propofol. And so to the end of the of samples , the above pattern is used , Blinding description: The participant, the clinical caregiver and data analyser are not aware of the type of drug used, and only the researcher or the person other than above sofisticate the drug used (in an accidental manner) in an aluminum foil and give it to a clinical caregiver for injectin to the patient. 3 agitation due to sevoflurane gas. Intervention 1: Intervention Group: Receive 0.5mg/kg Propofol drug after agitation. Intervention 2: Control Group: Recieve 0.5mcg/kg Fentanyl drug after agitation. Yes - There is a plan to make this available What will be shared: I can send the fallowing upon request of the researchers:Participants data file, study protocol, clinical study report, the codes used in the analysis, data classification system When: One year after the print results To whom: Researchers in the University Conditions: Without any condition Where to obtain: Apply to my E.mail.adress How to obtain: One week Comments:
public Arash Amini
5th Fl, orkid app, Mobarakabad Ave, Behesht4, orkid app
Sanandaj Iran (Islamic Republic of) 6619765613 +98 87 3356 5863 arash.amini@muk.ac.ir Sanandaj University of Medical Sciences scientific Behzad Ahsan
Kosar hospital of Sanandaj
Sanandaj Iran (Islamic Republic of) 6617983476 +98 87 3361 1232 behzadahsan@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Children aged 2 to 10 years old Class one or two of ASA Children under general anesthesia with sevoflurane 2 years 10 years Both Children with growth retardation Children with psychological diseases Children with neurological disease Children with abnormal airway Irritable children XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention Group: Receive 0.5mg/kg Propofol drug after agitation Control Group: Recieve 0.5mcg/kg Fentanyl drug after agitation Agitation Score. Timepoint: 5 ,10 ,15 ,20 minute after the treatment of Agitation. Method of measurement: RASS (Richmond agitation sedation scale). Vomiting. Timepoint: 5,10,15,20 minutes after injection of propofol or fentanyl. Method of measurement: In the form of positive or Negative by watching and reporting the caregiver. Nausea. Timepoint: 5,10,15,20 minutes after injection of propofol or fentanyl. Method of measurement: In the form of positive or Negative by watching and reporting the caregiver. Sanandaj University of Medical Sciences Approved 2018-10-20 Ethics commitee of Kurdestan University of Medical Sciences Pasdaran St, Kurdestan University of Medical Science Sanandaj Kurdistan Iran (Islamic Republic of)