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IRCT20141209020258N168 IRCT 2021-11-05 Arak University of Medical Sciences Comparison of the effect of adding midazolam, paracetamol, tramadol and magnesium sulphate to ‎ropivacaine in reducing pain Comparison of the effect of adding midazolam, paracetamol, tramadol and magnesium sulphate to ‎ropivacaine in reducing pain and hemodynamic changes in intravenous local anesthesia 2021-11-22 anticipated 160 Complete https://irct.ir/trial/59606 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 5 groups using a permuted balanced block randomization method with the size of blocks 3 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: It is a double-blind study. Analysts, evaluators, and participants are unaware of the grouping.The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern, and the patients are not aware of their group. 3 Forarm surgery. Intervention 1: Intervention group 1: 50 milligram in kilogram of magnesium sulfate 50% made by Shahid Ghazi Pharmaceutical Company of Tabriz with rupivacaine two tenths of a percent will inject. Intervention 2: Intervention group 2: 200 milligram of paracetamol made by Tehran Shimi Company with Rupivacaine two tenths of a percent will inject. Intervention 3: Intervention group 3: 100 mg of tramadol made by Caspian Tamin Rasht Company - Iran with Rupivacainetwo tenths of a percent will inject. Intervention 4: Intervention group 4: 50 micro geram in kilogram midazolam made by Caspian Tamin Rasht - Iran with Rupivacainetwo tenths of a percent will inject. Intervention 5: Control group: 5 ml of normal saline with 35 ml of rupivacaine two tenths of a percent with a total volume of 40 ml will be injected intravenously. 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 Dr Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Candidate of forearm surgery ASA class 1 and 2 No Raynaud's disease Absence of any vascular disease No sickle cell anemia No history of allergy to the drugs used in the study Lack of cyanosis of the affected limb Do not use drugs and psychotropic substances No contraindication to intravenous anesthesia No more than one fracture in the body or surgery Absence of chronic pain syndrome Absence of neurological disorders in the hand 20 years 65 years Both For any reason, local intravenous anesthesia may be terminated during surgery Not consent to participate in study Duration of operation less than 30 minutes or more than 90 minutes S55.001S Unspecified injury of ulnar artery at forearm level, right arm, sequela Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: 50 milligram in kilogram of magnesium sulfate 50% made by Shahid Ghazi Pharmaceutical Company of Tabriz with rupivacaine two tenths of a percent will inject. Intervention group 2: 200 milligram of paracetamol made by Tehran Shimi Company with Rupivacaine two tenths of a percent will inject. Intervention group 3: 100 mg of tramadol made by Caspian Tamin Rasht Company - Iran with Rupivacainetwo tenths of a percent will inject. Intervention group 4: 50 micro geram in kilogram midazolam made by Caspian Tamin Rasht - Iran with Rupivacainetwo tenths of a percent will inject. Control group: 5 ml of normal saline with 35 ml of rupivacaine two tenths of a percent with a total volume of 40 ml will be injected intravenously. Sensory block. Timepoint: From the beginning study to 24 hours. Method of measurement: Physical examination. Motor block. Timepoint: From the beginning study to 24 hours. Method of measurement: Physical examination. Pain. Timepoint: After filling the tourniquet, 15, 30 and 45 minutes after the start of surgery and 30, 60, 90 and 120 minutes after the end of surgery. Method of measurement: Visual analogue pain questionnaire. Average use opioids. Timepoint: Within 24 hours after surgery. Method of measurement: View file. Arak University of Medical Sciences Approved 2021-10-10 Ethics Committe Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)