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IRCT20160307026950N28 IRCT 2020-12-09 Esfahan University of Medical Sciences The effect of Valsalva maneuver and tourniquet closure on Propofol injection pain Comparison of the effectiveness of tourniquet ligation and Valsalva maneuver in relieving pain caused by Propofol injection to induce general anesthesia 2020-12-21 anticipated 105 Complete https://irct.ir/trial/51293 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done by block method; As the number of patients in all three groups is the same, each patient is assigned a code using a random number table (Random allocation software) and patients enter one of the groups according to these codes, Blinding description: This is a double-blind study in which the clinical caregiver and the person injecting the drug are different from the person performing the intervention and are unaware of the intervention.Patients in each group are also told that in order to reduce the pain of injecting two Valsalva maneuvers and closing the tourniquet, they are also told that depending on their group, only one of these interventions can be real and may even The two interventions are not real to determine the effect of the intervention. Therefore, patients are not aware of the type of intervention and are kept blind. 3 Pain from propofol injection. Intervention 1: Intervention group A: Patients first receive 2 ml of normal saline intravenously and after 3 minutes while the tourniquet is closed schematically, they perform the Valsalva maneuver by blowing in a plastic tube for at least 20 seconds. Propofol injection begins at the end of the Valsalva maneuver. Intervention 2: Intervention group B: First the tourniquet is closed and then 2 ml of normal saline is given intravenously and then 30 seconds later, while there is a plastic tube for schematic of Valsalva maneuver, intravenous propofol is injected and then the tourniquet is released. Intervention 3: Control group C: There is both a tourniquet and a plastic tube, but the intervention is performed schematically and patients receive 2 ml of normal saline intravenously and then intravenous propofol injection is started. 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 more information
public Zahra Sajad
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 Zahrasajad1995@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years ASA class I and II candidate for surgery under the general anesthesia Able to perform Valsalva maneuver 18 years 65 years Both Having respiratory problems Drug addiction and stimulants Allergy to Propofol Having underlying diseases such as diabetes, cardiovascular problems, liver disorders Existence of chronic pain syndromes and thrombophlebitis Take any analgesic and sedative before anesthesia G89 Pain, not elsewhere classified Prevention Prevention Placebo Intervention group A: Patients first receive 2 ml of normal saline intravenously and after 3 minutes while the tourniquet is closed schematically, they perform the Valsalva maneuver by blowing in a plastic tube for at least 20 seconds. Propofol injection begins at the end of the Valsalva maneuver. Intervention group B: First the tourniquet is closed and then 2 ml of normal saline is given intravenously and then 30 seconds later, while there is a plastic tube for schematic of Valsalva maneuver, intravenous propofol is injected and then the tourniquet is released. Control group C: There is both a tourniquet and a plastic tube, but the intervention is performed schematically and patients receive 2 ml of normal saline intravenously and then intravenous propofol injection is started. Pain from propofol injection. Timepoint: 20 seconds after propofol injection. Method of measurement: withdrawal response score questionnaire. Blood Pressure. Timepoint: Before intervention, after intervention, after injection of propofol every 1 to 3 minutes, 5 minutes after induction of anesthesia, 10 minutes after induction of anesthesia. Method of measurement: Barometer. Heart Rate. Timepoint: Before intervention, after intervention, after injection of propofol every 1 to 3 minutes, 5 minutes after induction of anesthesia, 10 minutes after induction of anesthesia. Method of measurement: ECG monitoring. Arterial blood oxygen saturation. Timepoint: Before intervention, after intervention, after injection of propofol every 1 to 3 minutes, 5 minutes after induction of anesthesia, 10 minutes after induction of anesthesia. Method of measurement: Pulse Oximeter. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2020-10-16 Isfahan University of Medical Sciences Committe for Ethics in Biomedical Research Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)