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IRCT20170716035104N5 IRCT 2021-10-27 Esfahan University of Medical Sciences Aminophylline and metoclopramide in pain after vitrectomy Evaluating the preemptive effect of metoclopramide and aminophylline on pain after deep vitrectomy 2017-05-25 anticipated 102 Complete https://irct.ir/trial/59146 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are listed according to referral to surgical centers, arranged from one to 105, respectively. These numbers are then randomly divided into three groups (each will contain 35 cases) by Random Allocation Software (available at: http://ftp.mui.ac.ir/RA.zip). The software is set to generate numbers in a single block, based on numeric and sequential coding with a length of three digits. By hitting the Generate key, numbers from one to 105 are randomly assigned to each of the three groups defined in this study (metoclopramide, aminophylline, and placebo). The output list is copied from the software and will be copied in Microsoft Excel software, Blinding description: An anesthesiologist who will be unaware of the study methods would prepare the drugs in similar syringes and label them with random numbers to be delivered to the study conductor. Patients will be also unaware of the type of medication they receive. 3 Pain intensity after deep vitrectomy. Intervention 1: The first intervention group will receive 0.1 mg/kg of metoclopramide by intravenous infusion for ten minutes, 15 minutes before the end of surgery. Intervention 2: The second intervention group will receive 4 mg/kg of aminophylline by intravenous infusion for ten minutes, 15 minutes before the end of surgery. Intervention 3: Patients in the control (placebo group) will receive 10 ml of intravenous normal saline for ten minutes, 15 minutes before the end of surgery. 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 The information of this trial has been provided to the Vice-Chancellor for Research of Isfahan University of Medical Sciences. In case of cooperation of the mentioned deputy for publishing the data file, information will be provided.
public Daroush Moradi Farsani
Isfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
Esfahan Iran (Islamic Republic of) 7346181746 +98 31 3620 1992 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Daroush Moradi Farsani
Isfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
Esfahan Iran (Islamic Republic of) 7346181746 +98 31 3620 1992 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients undergoing pars plana deep vitrectomy (20G) surgery Age between 18 to 75 years Status classification I or II according to the American Society of Anesthesiologists (ASA) Status Classification System Body mass index (BMI) less than 35 Ability to speak Written informed consent 18 years 75 years Both History of taking corticosteroids and immunosuppressants since one month before surgery History of allergies to metoclopramide or aminophylline, Taking metoclopramide, aminophylline, or any other analgesics 24 or less than 24 hours before surgery, History of malignancy, uncontrolled diabetes, smoking cigarettes, addictive drugs, and alcohol abuse, chronic pain for more than six months, mental illness, evident preoperative anxiety or tachycardia, history of taking anti-anxiety or anti-arrhythmic medications, and a history of general anesthesia by using volatile anesthetics, in the last six months Z98.89 Other specified postprocedural states Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group will receive 0.1 mg/kg of metoclopramide by intravenous infusion for ten minutes, 15 minutes before the end of surgery. The second intervention group will receive 4 mg/kg of aminophylline by intravenous infusion for ten minutes, 15 minutes before the end of surgery. Patients in the control (placebo group) will receive 10 ml of intravenous normal saline for ten minutes, 15 minutes before the end of surgery. Patient's post-operative pain intensity. Timepoint: At the beginning of admission at the recovery ward, then at 30 and 60 minutes and 2, 4, 8, 16, and 24 hours after entering the recovery ward. Method of measurement: The Visual Analog Scale (VAS). Mean of blood pressure (mm Hg). Timepoint: During surgery (once), in the recovery ward, and 8 hours after the surgery. Method of measurement: Clinical mercury manometer. Heart rate (beats per minute). Timepoint: During surgery (once), in the recovery ward, and 8 hours after the surgery. Method of measurement: Beat count by palpating distal radius pulse. Respiratory rate (breaths per minute). Timepoint: During surgery (once), in the recovery ward, and 8 hours after the surgery. Method of measurement: Capnometry. Pethidine required for sedation. Timepoint: Whenever the visual analog scale scores more than 3. Method of measurement: It is measured by counting the number of pethidine injections up to the end of 24 hours after admission to the recovery ward. The patients’ satisfaction status. Timepoint: Until the end of 24 hours after entering the recovery ward. Method of measurement: Questionnaire (completely satisfied, relatively satisfied, relatively dissatisfied, and completely dissatisfied). Recovery time. Timepoint: Until the end of 24 hours after entering the recovery ward. Method of measurement: Timer. Esfahan University of Medical Sciences Approved 2017-05-22 The Ethics committee of Esfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan, Iran. Esfahan Isfehan Iran (Islamic Republic of)