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IRCT20160307026950N27 IRCT 2020-11-18 Vice Chancellor for Research, Isfahan University of Medical Sciences The effect of Valsalva maneuver, Lidocaine and Valsalva maneuver and Lidocaine injection on reducing the pain of Propofol injection Comparison of three methods of Valsalva maneuver, Lidocaine, and Valsalva maneuvers along with administration of Lidocaine to reduce the pain associated with administration of Propofol 2020-11-24 anticipated 111 Complete https://irct.ir/trial/52122 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization is used in this study to devide cases in 3 groups. SAS algorithm was used to perform blocked randomization. 2 Local injection site pain. Intervention 1: Intervention group: The patient is asked to perform Valsalva maneuver at the time of propofol injection. Intervention 2: Intervention group: Intravenous Lidocaine bolus injection of 1mg/Kg of body weight, over 2-3 minutes. Intervention 3: Intervention group: The patient is asked to perform Valsalva maneuver at the time of propofol injection. In the meantime intravenous Lidocaine bolus dose of 1mg/Kg of body weight, is injected over 2-3 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is a possibility that our subjects would not be willing to consent to their data being shared.
public Behzad Nazem roaya
Hezar Jarib blvd.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3662 0048 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib blvd
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8597 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidates for general anesthesia Physical condition in ASA class I and II Age 18 to 65 years old Able to perform Valsalva maneuver 18 years 65 years Both History of mental, cardiac and respiratory diseases Chronic pain disorders Long history of analgesic use History of allergies to propofol and Lidocaine History of drug abuse G89.18 Other acute postprocedural pain Prevention Prevention Prevention Intervention group: The patient is asked to perform Valsalva maneuver at the time of propofol injection. Intervention group: Intravenous Lidocaine bolus injection of 1mg/Kg of body weight, over 2-3 minutes Intervention group: The patient is asked to perform Valsalva maneuver at the time of propofol injection. In the meantime intravenous Lidocaine bolus dose of 1mg/Kg of body weight, is injected over 2-3 minutes. Local propofol injection site pain measured by visual analog scale. Timepoint: Right after propofol injection. Method of measurement: visual analog scale / Objective physician-assessed pain score; with: 0= no pain;1= mild pain, pain that only is reported by the patient, and no signs of pain are observed by the physician;2= Moderate pain, one pain sign is observed in addition to patient's report3= Severe pain with loud noise or moaning. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2020-10-27 Isfahan University of Medical Sciences Committe for Ethics in Biomedical Research Isfahan University of Medical Sciences, Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)