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IRCT20170301032837N2 IRCT 2017-12-03 Iran University of Medical Sciences The effect of infusion of propofol before it's induction dose on injection pain Comparative study of the effect of propofol infusion before injection of induction dose on injection induced pain and changes in serum complement in patients candidate for general anesthesia 2017-02-13 anticipated 60 Complete https://irct.ir/trial/25486 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, simple randomization method is used using sealed envelope. The patient chooses one of the three envelopes, in which the letters A, B, C are written, and is placed in one of the three groups, Blinding description: During the study, the patient is simply blind because of the lack of knowledge about how the anesthetic induction was performed.The laboratory, which is responsible for assessing the serum level of complementary C3 factor, is blind. The researcher is involved in the induction of anesthesia and intervention, and is not blind to the type of intervention and non-intervention. N/A Pain caused by propofol injection. Intervention 1: Control group: After IV catheterizationin the patient's hand, 5 cc blood samples are taken to measure the serum level of complement factor C3. One minute later fentanyl 3 micg/kg and midazolam 0.15 mg/kg is injected. One minute later, general anesthesia is induced with propofol 2 mg/kg and atracurium 0.5 mg/kg.One minute later, 5 cc blood sample are taken from the same hand and above the injection site to measure the serum level of factor C3.During injection of Bolus Propofol, pain intensity is assessed by VAS. Intervention 2: Intervention group 1: After intravenous catheterization, 5 cc blood samples are taken to measure the serum level of complement factor C3.Then propofol infusion 50μg/kg/min ( Manufactured by: Fresenius Kabi Ausria GmbH A-8055 Graz , Austria ) is administered for one minute. Then fentanyl 3 μg/kg and midazolam 0.15 mg/kg are injected.One minute later, general anesthesia is induced with propofol 2 mg/kg and atracurium 0.5 mg/kg.One minute later, 5 cc blood sample are taken from the same hand and above the injection site to measure the serum level of factor C3.During injection of Bolus Propofol, pain intensity is assessed by VAS. Intervention 3: Intervention group 2: After intravenous catheterization, 5 cc blood samples are taken to measure the serum level of complement factor C3.Then propofol infusion 100μg/kg/min ( Manufactured by: Fresenius Kabi Ausria GmbH A-8055 Graz , Austria ) is administered for one minute. Then fentanyl 3 μg/kg and midazolam 0.15 mg/kg are injected.One minute later, general anesthesia is induced with propofol 2 mg/kg and atracurium 0.5 mg/kg.One minute later, 5 cc blood sample are taken from the same hand and above the injection site to measure the serum level of factor C3.During injection of Bolus Propofol, pain intensity is assessed by VAS. Yes - There is a plan to make this available What will be shared: All information used for this research can be shared after unidentifying the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared. When: Starting access after accepting by a valid scientific journal and publishing it To whom: For academic researchers and in the field of science Conditions: All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned. Where to obtain: Dr. Behrooz Zaman Email: zaman.b@iums.ac.ir How to obtain: The applicant can request the type of files by email. Comments:
public Behrooz Zaman
Iran university of medical sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8871 7272 zaman.b@iums.ac.ir Iran University of Medical Sciences scientific Behrooz Zaman
Iran university of medical sciences
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8871 7272 zaman.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients are candidates for general anesthesia ASA I & II 18 years 60 years Both uncontrolled chronic and acute diseases age >60 age<18 history of hypersensitivity to drugs and foods History of using NSAIDS and corticostroides opioid addiction T41.1X5 Adverse effect of intravenous anesthetics Other Prevention Prevention Control group: After IV catheterizationin the patient's hand, 5 cc blood samples are taken to measure the serum level of complement factor C3. One minute later fentanyl 3 micg/kg and midazolam 0.15 mg/kg is injected. One minute later, general anesthesia is induced with propofol 2 mg/kg and atracurium 0.5 mg/kg.One minute later, 5 cc blood sample are taken from the same hand and above the injection site to measure the serum level of factor C3.During injection of Bolus Propofol, pain intensity is assessed by VAS. Intervention group 1: After intravenous catheterization, 5 cc blood samples are taken to measure the serum level of complement factor C3.Then propofol infusion 50μg/kg/min ( Manufactured by: Fresenius Kabi Ausria GmbH A-8055 Graz , Austria ) is administered for one minute. Then fentanyl 3 μg/kg and midazolam 0.15 mg/kg are injected.One minute later, general anesthesia is induced with propofol 2 mg/kg and atracurium 0.5 mg/kg.One minute later, 5 cc blood sample are taken from the same hand and above the injection site to measure the serum level of factor C3.During injection of Bolus Propofol, pain intensity is assessed by VAS. Intervention group 2: After intravenous catheterization, 5 cc blood samples are taken to measure the serum level of complement factor C3.Then propofol infusion 100μg/kg/min ( Manufactured by: Fresenius Kabi Ausria GmbH A-8055 Graz , Austria ) is administered for one minute. Then fentanyl 3 μg/kg and midazolam 0.15 mg/kg are injected.One minute later, general anesthesia is induced with propofol 2 mg/kg and atracurium 0.5 mg/kg.One minute later, 5 cc blood sample are taken from the same hand and above the injection site to measure the serum level of factor C3.During injection of Bolus Propofol, pain intensity is assessed by VAS. Pain intensity. Timepoint: At the time of the intervention. Method of measurement: visual analogue scale of pain. Changes in serum level of complement factor C3. Timepoint: Immediately before the intervention and two minutes after the intervention. Method of measurement: Blood sampling and laboratory measurements. Iran University of Medical Sciences Approved 2017-02-12 Ethics committee of Iran University of Medical Sciences Hemmat highway Tehran Tehran Iran (Islamic Republic of)