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IRCT20220719055498N1 IRCT 2022-08-10 Arak University of Medical Sciences effect of Lidocaine , esmolol and ketorolac in pain control when injecting rocuronium Comparison of pretreatment with Lidocaine , esmolol and ketorolac in pain control when injecting rocuronium 2022-09-23 anticipated 176 Complete https://irct.ir/trial/64862 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, as every group must have the same number of participants, block randomization method will be performed, and in order to avoid prediction of the last assignment in the block, block size will be chosen randomly (in 4s or 8s). If the randomized blocks all have the same size, there is a risk of predictability; for example in blocks of four with equal participants in control and intervention groups, with the assignment of the first 3 slots, the last one is easily predicted, Blinding description: This study is double-blinded, hence the participants and the investigator responsible for gathering data are unaware of the drugs prescribed, and of the group assignments. we explain to the participants that they will be assigned to each of 4 groups and administrated a drug, labeled A, B, C or D on the syringe. only the Anesthetist is aware of the contents of each syringe and the participants and the investigator recording the data, will not have this information. 3 pain during Rocuronium injection in general anesthesia induction. Intervention 1: Intervention group 1: group K, 10 mg ketorolac (Exir Iran pharmaceutical company) injection in 2 ml in the left arm and 2 mg of 0.9% Normal Saline simultaneously in the the right arm. Intervention 2: Intervention group 2: group S, 0.5 mg/kg Esmolol (ORPHA-DEVEL pharmaceutical company) injection in 2 ml in the left arm and 2 mg of 0.9% Normal Saline simultaneously in the the right arm. Intervention 3: Intervention group 3: group L, 1 mg/kg Lidocaine (Caspian Iran company) injection in 2 ml in the left arm and 2 mg of 0.9% Normal Saline simultaneously in the the right arm. Intervention 4: Control group: group P, 2 ml of Normal Saline simultaneously in both arms. Yes - There is a plan to make this available What will be shared: Participant data file (IPD), the data of the study participants is uploaded as an Excel file.The study protocol, informed consent form, clinical study report will be uploaded as a word file. When: The access period starts 6 months after the results are published To whom: All researchers in the country can access the uploaded data. Conditions: There are no special conditions for receiving data, and all researchers can get the uploaded information if the access to the system is open. Where to obtain: All the information and documents of this study are placed in the research system of Arak University of Medical Sciences (Pajhuhan), whose address is http://vdresearch.arakmu.ac.ir/general /homePage.action and also after the completion of the study, all its information will be registered in the Irandoc system at the address https://irandoc.ac.ir/, applicants can refer to these addresses and enter the title study to access the desired data How to obtain: The information requester first refers to the Arak medical sciences research system and by searching the name of the first author or the responsible author of the desired article, the related research file will be available, which is usually open to researchers in this system. Register the title of the article and get access to its documents. Comments:
public Nazanin Hassannejad
No.67, Shahid Taheri Alley, Keshavarzi Street, Keshavarz Blvd, Esfahan
Esfahan Iran (Islamic Republic of) 8174845751 +98 31 3777 5374 nazaninhasannejad.md@gmail.com Arak University of Medical Sciences scientific Hesameddin Modir
Valiasr hospital, Valiasr square, Arak, Markazi
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2004 he_modir@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Elective surgery candidates undergoing general anesthesia ASA class I and II 18 years 50 years Both History of Thrombophlebitis, vascular disease, chronic pain, Diabetes History of burns, and tumors in the hand with the catheter History of addiction or any contraindications for the drugs used in the study Not consenting to participate in the study Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: group K, 10 mg ketorolac (Exir Iran pharmaceutical company) injection in 2 ml in the left arm and 2 mg of 0.9% Normal Saline simultaneously in the the right arm Intervention group 2: group S, 0.5 mg/kg Esmolol (ORPHA-DEVEL pharmaceutical company) injection in 2 ml in the left arm and 2 mg of 0.9% Normal Saline simultaneously in the the right arm Intervention group 3: group L, 1 mg/kg Lidocaine (Caspian Iran company) injection in 2 ml in the left arm and 2 mg of 0.9% Normal Saline simultaneously in the the right arm Control group: group P, 2 ml of Normal Saline simultaneously in both arms Visual analog scale pain scores. Timepoint: during and 1 minute after Rocuronium injection. Method of measurement: visual analog scale pain. Mean arterial blood pressure. Timepoint: on entering the operation room, 5 minutes and ten minutes after injection of intervention drugs, at the time of induction and every 10 minutes after induction for 30 minutes. Method of measurement: Sphygmomanometer. Arterial oxygen saturation. Timepoint: on entering the operation room, 5 minutes and ten minutes after injection of intervention drugs, at the time of induction and every 10 minutes after induction for 30 minutes. Method of measurement: pulse oximetry. Heart beat. Timepoint: on entering the operation room, 5 minutes and ten minutes after injection of intervention drugs, at the time of induction and every 10 minutes after induction for 30 minutes. Method of measurement: taking Radial pulse for 1 minute. Arak University of Medical Sciences Approved 2022-06-26 Ethics committee of Arak university of Medical Sciences Arak university of Medical Sciences, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)