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IRCT20170404033202N10 IRCT 2022-03-23 Sabzevar University of Medical Sciences Comparison of the cold normal saline, lidocaine and metoclopramide and the combination of lidocaine and cold normal saline on pain caused by propofol injection Comparison of the cold normal saline, lidocaine and metoclopramide and the combination of lidocaine and cold normal saline on pain caused by propofol injection 2021-11-22 anticipated 120 Complete https://irct.ir/trial/59665 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be selected at random using the most available people for the study. Each person was given a code A or B at random (sheet or envelope) and treatment was performed based on it (group A was intervention and group B was control), Blinding description: In all groups, the amount of pain at 0, 15, and 30 minutes after propofol injection is assessed by another observer who is unaware of the type of drug being injected, based on the VAS, from zero to 10 (zero painless, 10 severe pain). Outcome assessment is also done by someone who does not know about the groups. 3 Reduction of pain caused by propofol in anesthesia. Intervention 1: Intervention group 1: The case group consisting of four groups including the first group will inject 10 ml of 0.5% lidocaine at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Intervention 2: Intervention group 2: The second group will inject 10 ml of normal serum cold saline 4 degrees at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Intervention 3: Intervention group 3: The third group will inject 10 ml of 0.5% lidocaine with 10 cc of normal saline 4 ° at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Intervention 4: Intervention group4: The fourth group will be injected with 10 mg metoclerine pyramid at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Intervention 5: Control group: The control group will be injected with 10 ml of normal saline at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. 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 No more information
public Mohammad Nematshahi
Asadabadi St., Central Organization of Sabzevar University of Medical Sciences
Sabzwvar Iran (Islamic Republic of) 913885697 098 51 44229081 9151737407mn@gmail.com Sabzevar University of Medical Sciences scientific Mohammad Nematshahi
Asadabadi St., Central Organization of Sabzevar University of Medical Sciences
Sabzevar Iran (Islamic Republic of) 9613885697 +98 51 4422 9081 9151737407mn@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Need for general anesthesia with propofol injection with consent to participate in evaluation between 18 and 60 years old ASA class 1 and 2 18 years 60 years Both Reluctance to studyPatients Patients under 20 years and over 60 years Patients with ASA grade equal to or greater than 3 Patients with advanced heart and lung problems Sensitivity to any of the drugs used in the study Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: The case group consisting of four groups including the first group will inject 10 ml of 0.5% lidocaine at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Intervention group 2: The second group will inject 10 ml of normal serum cold saline 4 degrees at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Intervention group 3: The third group will inject 10 ml of 0.5% lidocaine with 10 cc of normal saline 4 ° at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Intervention group4: The fourth group will be injected with 10 mg metoclerine pyramid at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Control group: The control group will be injected with 10 ml of normal saline at room temperature. The tourniquet is emptied 15 seconds after the injection. Propofol 50 mg 1% in a volume of 5 ml is then injected into all three groups within 5 seconds. In all groups, the amount of pain at 0 and 10 minutes after propofol injection was assessed by another observer who was unaware of the type of drug being injected, according to Wang Baker. Induction of anesthesia and intubation is performed with 2 mg midazolam, 1.5 / kg fentanyl, the remaining dose of propofol (total dose 2.5 mg / kg and 0.6 mg / kg atracurium. Also, heart rate, mean blood pressure before Drug injection and before induction to evaluate the effect of pain on hemodynamics and immediately after intubation and 5 minutes after intubation to evaluate the effect of lidocaine and propofol on hemodynamics. Reduction of pain caused by propofol injection after drug injection. Timepoint: Pain rate at 0, 15 and 30 minutes after propofol injection. Method of measurement: Based on VAS from zero to 10. Sabzevar University of Medical Sciences Approved 2021-10-12 Sabzevar Medical Sciences Sabzevar Medical Sciences Campus Sabzevar Razavi Khorasan Iran (Islamic Republic of)