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IRCT20180723040570N5 IRCT 2020-06-27 Iran University of Medical Sciences Effects of different doses of Naloxone on postoperative hyperparathyroidism Study of the effect of different doses of Naloxone on postoperative hyperalgesia in patients receiving high-dose RemiFentanyl in hysterectomy surgeries 2020-07-21 anticipated 30 Complete https://irct.ir/trial/48155 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, all eligible patients were assigned to three groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes, Blinding description: Participants and outcome assessors are unaware of the type of group and the type of intervention. 3 Hysterectomy. Intervention 1: Intervention group 1: Naloxone infusion with a dose of 0.05 μg / kg / min will be arranged by the completion of the surgery. Naloxone is produced by "Tolid daro" company of Iran. Intervention 2: Intervention group 2: Naloxone Infusion with a dose of 0.02 μg / kg / min will be arranged by the completion of the surgery. Naloxone is produced by "Tolid daro" company of Iran. Intervention 3: Control group: Normal saline with a dose of 0.2 cc per kg will be injected instead of Naloxone. Yes - There is a plan to make this available What will be shared: All individual data of the participants in this study will be shared after unidentifiable individuals When: The access period will start from 2021to 2022 To whom: Data will be available to researchers working in the university. Conditions: Just for performing research Where to obtain: Refer to the responsible person for accessing the data How to obtain: The data will be available one month after the responsible person's approval Comments:
public Nasim Nikoubakht
Rasool Akram, Maziar Mansory Ave, Satarkhan Ave.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 64351 Nikoobakht.n@iums.ac.ir Iran University of Medical Sciences scientific Nasim Nikoubakht
No.24, Kashfian Ave., Sheykhbahayy Ave., Molasadra Ave., Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 9854 nikoobakht.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients candidate for hysterectomy َASA 1&2 No drug allergy 20 years 80 years Both Addiction َََAlcohol consumption N99.3 Prolapse of vaginal vault after hysterectomy Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Naloxone infusion with a dose of 0.05 μg / kg / min will be arranged by the completion of the surgery. Naloxone is produced by "Tolid daro" company of Iran. Intervention group 2: Naloxone Infusion with a dose of 0.02 μg / kg / min will be arranged by the completion of the surgery. Naloxone is produced by "Tolid daro" company of Iran. Control group: Normal saline with a dose of 0.2 cc per kg will be injected instead of Naloxone. Visual Analogue Scale. Timepoint: 30 minutes before surgery and 1, 2 , 8 and 24 hours after surgery. Method of measurement: Patient's answer. Ramsy score. Timepoint: 30 minutes before surgery and 1, 2 , 8 and 24 hours after surgery. Method of measurement: Patient's answer. Pinprick test. Timepoint: 30 minutes before surgery and 1, 2 , 8 and 24 hours after surgery. Method of measurement: Patient's answer. Iran University of Medical Sciences Approved 2020-01-28 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Milad tower, Hemmat highway, Tehran Tehran Tehran Iran (Islamic Republic of)