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IRCT20221017056211N1 IRCT 2022-10-24 Iran University of Medical Sciences The effect of neostigmine drug on the onset and intensity of regional anesthesia in upper limb surgery Comparison of the effect of neostigmine and placebo in combination with ropivacaine on the onset and severity of axillary block in patients undergoing hand and forearm surgery. 2022-10-23 anticipated 40 Complete https://irct.ir/trial/66337 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block 4, we divide patients into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, patients, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B. 3 Upper extremity surgery. Intervention 1: Intervention group: After obtaining informed consent, patients are divided into two groups. After standard monitoring is connected, 200cc of Ringer's serum is injected, patients are sedated by injecting 0.15mg/kg midazolam and 1.5μg/kg fentanyl. Then, with the simultaneous use of ultrasound and neurostimulator, the brachial plexus nerves were identified in the axillary region, and in the first group, 30 cc of 0.5% ropivacaine (Made by Jalinous Pharmaceutical Company) and 500 μg of neostigmine (Made by Jalinous Pharmaceutical Company) (31 cc in total) were injected for axillary block. Then, the onset time and intensity of regional anesthesia are recorded using a suitable questionnaire. Intervention 2: Control group: After obtaining informed consent, patients are divided into two groups. After standard monitoring is connected, 200cc of Ringer's serum is injected, patients are sedated by injecting 0.15mg/kg midazolam and 1.5μg/kg fentanyl. Then, with the simultaneous use of ultrasound and neurostimulator, the brachial plexus nerves were identified in the axillary region, and in the first group, 30 cc of 0.5% ropivacaine (Made by Jalinous Pharmaceutical Company) and One cc of distilled water (Made by Jalinous Pharmaceutical Company) (31 cc in total) were injected for axillary block. Then, the onset time and intensity of regional anesthesia are recorded using a suitable questionnaire. 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 further information.
public Elham Shasti
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8894 6762 Shastielham@yahoo.com Iran University of Medical Sciences scientific Elham Shasti
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8894 6762 Shastielham@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Candidate patients for hand and forearm surgery Patients with ASA I, II anesthesia level 18 years 70 years Both Allergy to local anesthetics Congenital and acquired neuromuscular diseases L02.52 Furuncle hand Treatment - Drugs Placebo Intervention group: After obtaining informed consent, patients are divided into two groups. After standard monitoring is connected, 200cc of Ringer's serum is injected, patients are sedated by injecting 0.15mg/kg midazolam and 1.5μg/kg fentanyl. Then, with the simultaneous use of ultrasound and neurostimulator, the brachial plexus nerves were identified in the axillary region, and in the first group, 30 cc of 0.5% ropivacaine (Made by Jalinous Pharmaceutical Company) and 500 μg of neostigmine (Made by Jalinous Pharmaceutical Company) (31 cc in total) were injected for axillary block. Then, the onset time and intensity of regional anesthesia are recorded using a suitable questionnaire. Control group: After obtaining informed consent, patients are divided into two groups. After standard monitoring is connected, 200cc of Ringer's serum is injected, patients are sedated by injecting 0.15mg/kg midazolam and 1.5μg/kg fentanyl. Then, with the simultaneous use of ultrasound and neurostimulator, the brachial plexus nerves were identified in the axillary region, and in the first group, 30 cc of 0.5% ropivacaine (Made by Jalinous Pharmaceutical Company) and One cc of distilled water (Made by Jalinous Pharmaceutical Company) (31 cc in total) were injected for axillary block. Then, the onset time and intensity of regional anesthesia are recorded using a suitable questionnaire. Regional anesthesia onset time. Timepoint: During of surgery. Method of measurement: Using a timer. Regional anesthesia intensity. Timepoint: During surgery. Method of measurement: A questionnaire designed by the researcher using the patient's information and the anesthesiologist's opinion. Pain from surgery. Timepoint: During surgery. Method of measurement: Using the Visual Analogue Scale pain questionnaire. Iran University of Medical Sciences Approved 2022-06-01 Ethics committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)