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IRCT20201213049697N1 IRCT 2021-09-07 Esfahan University of Medical Sciences Comparison of preventive effects of Ketamine ,fentanyl and paracetamol on Hemodynamic parameters and acute postoperative pain after deep vitrectomy Comparison of preventive effects of Ketamine ,fentanyl and paracetamol on Hemodynamic parameters and acute postoperative pain after deep vitrectomy 2020-12-16 anticipated 80 Complete https://irct.ir/trial/52976 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Before starting the project, the sequence of patients in 4 groups is determined using random allocation software And patients are divided into 4 groups receiving ketamine (group K), group receiving fentanyl (group (f), group receiving paracetamol (group p) and control group It(drug) is delivered in covered syringes and has a code. The medicine is prepared by an operating room technician and the doctor is unaware of the contents of the syringe. Randomization is simple. It is an individual randomization unit. Randomization is done by random allocation, Blinding description: Prior to surgery, patients will be told that their pain intensity and hemodynamic parameters will be assessed after surgery, patients will be told if they are compared to other groups, and then their consent form will be obtained Becomes The medicine is prepared by an operating room technician and the doctor is unaware of the contents of the syringe In order for the study to be bi-blind, two different people will be used so that the anesthesiologist will prescribe the medication And the other person does not know the type of drug used Collects data and analyzes information. In fact, the drugs are prepared by the anesthesia technician and delivered to the anesthesiologist in sealed and numbered syringes. The anesthesiologist does not know the type of drug injected into the patient. Also, data related to the study during and after the operation will be collected and analyzed by someone other than the anesthesiologist and anesthesiology Technician. 3 Most cases of vitrectomy are performed due to retinal detachment for any reason, including diabetes, trauma, etc.. Intervention 1: Intervention group: Ketamine (Group K) 0.5mg / kg will be opened by intravenous infusion within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution .Drug of a special pharmaceutical factory is not consider .The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals. Intervention 2: Intervention group: The fentanyl group receiving 2mcg / kg will be infused intravenously within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution. Drug of a special pharmaceutical factory is not consider . The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals. Intervention 3: Intervention group: Paracetamol group receiving 10 mg / kg will be infused intravenously within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution. Drug of a special pharmaceutical factory is not consider . The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals. Intervention 4: Control group: 100 cc normal saline for 15 minutes intravenously. Yes - There is a plan to make this available What will be shared: In this study, only data related to the effect of drugs on hemodynamic parameters and acute postoperative pain will be published and potential data information will be published only after the necessary coordination with the executor and ensuring the scientific rank and purpose of the person requesting the information. When: One year after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The data will be provided to the mentioned people for comparative studies as well as systematic studies Where to obtain: razani113774@gmail.com ,Mohammad Razani, Isfahan University of Medical Sciences 09381793755 ,Mohammad Razani, Isfahan University of Medical Sciences How to obtain: Depending on the type of information requested, the person communicates with the researcher through the channels provided and finally receives his / her answer within one month. Comments:
public Darioush Moradi Farsani
Hezar Jerib St
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8138 drdmoradi@gmail.com Esfahan University of Medical Sciences scientific Darioush Moradi Farsani
Hezar jarib St
Esfahan Iran (Islamic Republic of) 8174673461 031 3668 81388 drdmoradi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) all patient candidate for deep vitrectomy surgery 40 years 80 years Both each surgery that long more than 3 or less than 1 hour pregnancy addiction to cigarette ,opium and alcohol Inability to speak non iranian nationality more than 100 kg weight choronic pain that last more than 6 month uncontroled systemic diseases such as liver or kidney disease allergy or anaphylaxy to NSAID ,opium and drug that we use in study psychosis ,obvious anxiety before surgery and History of taking anti-anxiety medication Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: Ketamine (Group K) 0.5mg / kg will be opened by intravenous infusion within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution .Drug of a special pharmaceutical factory is not consider .The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals. Intervention group: The fentanyl group receiving 2mcg / kg will be infused intravenously within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution. Drug of a special pharmaceutical factory is not consider . The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals. Intervention group: Paracetamol group receiving 10 mg / kg will be infused intravenously within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution. Drug of a special pharmaceutical factory is not consider . The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals. Control group: 100 cc normal saline for 15 minutes intravenously Hemodynamic changes (blood pressure, respiration rate, heart rate, blood oxygen saturation). Timepoint: Before the operation, during the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours), after the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours, 4 hours, 16 hours , 24 hours ). Method of measurement: Mercury sphygmomanometer, clock, pulse oximeter. Acute pain after surgery. Timepoint: Before the operation, during the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours), after the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours, 4 hours, 16 hours , 24 hours ). Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2020-12-03 Ethics Committee of Isfahan University of Medical Sciences esfahan university of medical science, Hezar jarib Ave ,Darvaze shiraz square esfahan Isfehan Iran (Islamic Republic of)