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IRCT20190121042444N5 IRCT 2024-02-11 Shahid Beheshti University of Medical Sciences "Investigation of the effect of anesthetic propofol on gene expression"; "Investigation of the effect of the anesthetic Isoflurane on gene expression" Comparison of the effects of two drugs, propofol and isoflurane, as anesthetic agents on gene expression mt-DNA in posterior vertebral fixation surgeries 2023-12-12 anticipated 34 Complete https://irct.ir/trial/74277 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants in the study are divided into two groups, control and intervention, using a randomizer software, so that at first, each patient is given a number by the researcher, and it is entered into the IZE Android software, and the output of the patient software is as It introduces groups A and B. 34 patients will be included in the study and will be divided into two groups of 17 people, Blinding description: Patients are introduced to the data collector to continue the study so that only the numbers A and B are written on the form in the patient's hand, and as a result, the patient and the data collector are not aware of the patient group. 3 Lumbar spine injury. Intervention 1: Intervention group: In order to induce anesthesia in all patients, midazolam 0.01 mg/kg, fentanyl 2 kg/mµ, lidocaine 1.5 mg/kg, propofol 2.5-2 mg/kg, and cis-etracurium 0.2 mg/kg will be administered. Then propofol with a dose of 0.1 to 0.2 mg/kg/min is used to maintain anesthesia in group one and isoflurane 1 to 2.5% is used by inhalation in group two. In addition, in both groups, atracurium and fentanyl were repeated every 45 minutes. Blood samples were taken in order to measure the mentioned variables once before induction (Baseline) and once one hour after anesthesia and 24 hours after the end of surgery. EDTA containing is collected. Intervention 2: Control group: No intervention will be performed in this group. Standard treatment will be administrated. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main consequence or the like, can be shared. When: Start of access period from 1402 To whom: Only for researchers in academic and scientific institutions Conditions: Only data analysis is possible Where to obtain: Dr. Faranak Behnaz, Address: Tehran, Tajrish Square, Shohada Experience Hospital, Tel: 0098212271174 How to obtain: After submitting the application, a maximum of one week will be answered Comments:
public Faranak Behnaz
Shohada Hospital, Tajrish SQ, Tehran , Iran
Tehran Iran (Islamic Republic of) 1985711151 009821227741174 faranak.behnaz@gmail.com Shahid Beheshti University of Medical Sciences scientific Mehrak Erfanian
Shohada Hospital,Tajrish SQ
Tehran Iran (Islamic Republic of) 1985711151 009821227741174 mehrak_erfanian@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for elective surgery for posterior stabilization of the lumbar spine ASA class I-II 20 years 70 years Both Previous history of surgery ASA class III or higher Malignancies Cardiovascular diseases Chronic inflammatory diseases Corticosteroid use Emergency surgery Any instability of the patient during surgery Drug addiction S30-S39 Injuries to the abdomen, lower back, lumbar spine and pelvis(S30-S39) Treatment - Drugs N/A Intervention group: In order to induce anesthesia in all patients, midazolam 0.01 mg/kg, fentanyl 2 kg/mµ, lidocaine 1.5 mg/kg, propofol 2.5-2 mg/kg, and cis-etracurium 0.2 mg/kg will be administered. Then propofol with a dose of 0.1 to 0.2 mg/kg/min is used to maintain anesthesia in group one and isoflurane 1 to 2.5% is used by inhalation in group two. In addition, in both groups, atracurium and fentanyl were repeated every 45 minutes. Blood samples were taken in order to measure the mentioned variables once before induction (Baseline) and once one hour after anesthesia and 24 hours after the end of surgery. EDTA containing is collected. Control group: No intervention will be performed in this group. Standard treatment will be administrated. Level of mt-DNA. Timepoint: before the intervention and 1 hour after the operation and 1 day after the operation. Method of measurement: Measurement of serum levels in a blood test. Duration of surgery. Timepoint: Surgery start time - surgery end time. Method of measurement: minutes. Bleeding volume. Timepoint: End of surgery. Method of measurement: milliliter. Complications of surgery. Timepoint: First of surgery- End of surgery. Method of measurement: Filling out the questionnaire. Demographic information. Timepoint: The beginning of surgery. Method of measurement: Filling out the questionnaire based on the birth certificate information. Shahid Beheshti University of Medical Sciences Approved 2023-11-26 Ethics committee of Shahid Behesti University of Medical Sciences Yaman Ave,Velenjak Tehran Tehran Iran (Islamic Republic of)