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IRCT20190422043340N1 IRCT 2019-05-14 Esfahan University of Medical Sciences Recovery Agitation after Administration of Ketadex, Ketofol and Ketamine Ketodex (=Ketamine and Dexmedetomidine) - Ketofol (=Ketamine and Propofol). The Comparison of Post-Operative Recovery Agitation after Three Analgesic Methods: Ketadex; Ketofol and Ketamine administration in the Emergency Departments in Iran 2019-06-22 anticipated 90 Complete https://irct.ir/trial/39080 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using Google™ Random Number Generator we will obtain 90 random numbers among 1, 2 and 3, print them out on a piece of paper, put them each into a closed envelope, and after each patient fulfills the inclusion criteria, the patient will be taken to the operation room of the emergency departments with an envelope, Blinding description: The nurse will use an analgesia induction drug based on the number in the envelope, after prepping the patient. Then, the nurse will discard the envelope, the drug, and the syringe and will call the physician in for continuing the procedure. The physician and the patient will not know what the drug the nurse has used or the group of the patient. 3 "recovery agitation". Intervention 1: Intervention group: Ketodex. Intervention 2: Intervention group: Ketofol. Intervention 3: Control group: Ketamine. Yes - There is a plan to make this available What will be shared: Data on agitation score and hemodynamic indices of the patients who are consciously informed and consented about the study and are included in the study will be shared. When: The data will be available from six months after the end of the patient recruitment and will be published as an article and will always be available. To whom: Everyone. Conditions: Everyone can use our data only after requesting and granting our permission. Where to obtain: Through email towards the person who has requested to have the data. How to obtain: Obtaining our email addresses and requesting throughout an email. Comments:
public Soheila Kouhestani
Isfahan University Of Medical Sciences, Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3661 7840 dr_kouhestani@yahoo.com Esfahan University of Medical Sciences scientific Soheila Kouhestani
Isfahan University of Medical Sciences, Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3661 7840 dr_kouhestani@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Female/Male age over 3 years American Society of Anesthesiology physical status I to III (ASA I-III) VAS score of pain equal to or higher than 4 need for painful procedures in Emergency Department such as: Reduction of extremity fracture or dislocation and repair of skin lacerations 3 years 65 years Both Patients showing serious adverse events of the drugs R45.1 Restlessness and agitation Prevention Prevention Prevention Intervention group: Ketodex Intervention group: Ketofol Control group: Ketamine Patient’s agitation and sedation consistency, assessed by RASS score (e.g. Richmond Agitation Sedation Scale). Timepoint: Patient’s agitation score and sedation consistency will be assessed by RASS score (Richmond Agitation Sedation Scale) within two minutes from induction of sedation and during recovery until 2 hours. Method of measurement: RASS score (Richmond Agitation Sedation Scale). Heart Rate, oxygen saturation, systolic and diastolic blood pressure. Timepoint: Every five minutes from the start point of analgesia induction until 2 two hours after full recovery. Method of measurement: sphygmomonometer for blood pressure, pulse oxymeter for heart rate and blood oxygen saturation. Esfahan University of Medical Sciences Approved 2017-04-12 Research Ethics Committee of Isfahan University of Medical Sciences and Health Services Research Ethics Committee, Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)