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IRCT20170716035104N1 IRCT 2018-12-29 Esfahan University of Medical Sciences Effect of Propofol and Isoflurane on Blood Glucose Level in Type 2 Diabetes Mellitus A Comparative Study on the Effect of Propofol and Isoflurane in Anesthetic Maintenance on Blood Glucose Level During Operation of Patients with Type 2 Diabetes Mellitus in Isfahan 2017-04-04 anticipated 110 Complete https://irct.ir/trial/35822 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be selected according to their referral to the surgical centers in this study. Using the random function command of Excell software, random numbers will be assigned to each patient by a person independent of the research team and then he/she prints the numbers on small pieces of paper. Then, the papers will be folded so the page with the numbers could not be seen. After putting the papers into a box, another independent person takes 55 paper pieces from the box and puts them into a section which is known as the Isoflurane group, and the other 55 pieces are put in the section known as the Propofol group, Blinding description: All patients will be blinded to the drugs that are used for their anesthesia. Because of the difference in the intended anesthetic techniques, the clinical caregiver cannot be blinded to the type of intervention he/she is conducting, but due to the concealment of the patient's profile before reading his/her case in the presence of the operating room secretary, the clinical caregiver would not have any knowledge about the patient's profile. The evaluator of the consequences obtains the required information for the study in the presence of the operating room secretary and is blinded to the patient's profile and the technique of anesthesia. The members of the Data Saftey and Monitoring Committee, the investigator and the analyst will be blinded to the patient's profile and the drugs he/she receives. 2-3 Type 2 diabetes mellitus. Intervention 1: The first intervention group (Isoflurane) would be first anesthetized with Fentanyl 2 micrograms per kilogram, Atracurium 0.6 milligrams per kilogram and Thiopental sodium 5 milligrams per kilogram of the body weight. Isoflurane 1-1.5% in a mixture of 50% oxygen and nitrous oxide (N2O) would be used for anesthetic maintenance. Intervention 2: In the second intervention group (Propofol), induction of anesthesia will be performed in patients with Fentanyl 2 micrograms per kilogram, Atracurium 0.6 milligrams per kilogram and Propofol 2 milligrams per kilogram of the body weight. Propofol will be used at a rate of 9 to 12 milligrams per kilogram of body weight per hour for anesthetic maintenance. 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 No further information is available.
public Mohammad Golparvar
Isfahan University of Medical Sciences, Hezar Jarib Ave.
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3235 0005 golparvar@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Golparvar
Isfahan University of Medical Sciences, Hezar Jarib Ave.
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3235 0005 golparvar@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Presence of type 2 diabetes mellitus Being a candidate for an elective surgery with general anesthesia The absence of drug allergy The absence of severe liver, kidney, heart or lung disorders An age between 15 and 65 years A duration of more than one hour for the surgical operation 15 years 65 years Both Patient's requirement for the prescription of Catecholamines during the anesthesia Not consenting to take part in the study Inability to continue participation in the study E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs The first intervention group (Isoflurane) would be first anesthetized with Fentanyl 2 micrograms per kilogram, Atracurium 0.6 milligrams per kilogram and Thiopental sodium 5 milligrams per kilogram of the body weight. Isoflurane 1-1.5% in a mixture of 50% oxygen and nitrous oxide (N2O) would be used for anesthetic maintenance. In the second intervention group (Propofol), induction of anesthesia will be performed in patients with Fentanyl 2 micrograms per kilogram, Atracurium 0.6 milligrams per kilogram and Propofol 2 milligrams per kilogram of the body weight. Propofol will be used at a rate of 9 to 12 milligrams per kilogram of body weight per hour for anesthetic maintenance. Blood glucose levels in patients with type 2 Diabetes Mellitus in milligrams per deciliter. Timepoint: Before surgery and an hour after starting the anesthetic maintenance. Method of measurement: The patient's blood sample will be sent to a reference laboratory to measure blood glucose levels. Heart rate (beats per minute). Timepoint: Before surgery, 15th minute of surgery, 30th minute of surgery, 45th minute of surgery, 60th minute of surgery and in the recovery. Method of measurement: Beat count by palpating distal radius pulse. Mean atrial pressure (mm Hg). Timepoint: Before surgery, 15th minute of surgery, 30th minute of surgery, 45th minute of surgery, 60th minute of surgery and in the recovery. Method of measurement: Clinical mercury manometer. Peripheral capillary oxygen saturation (percentage). Timepoint: Before surgery, 15th minute of surgery, 30th minute of surgery, 45th minute of surgery, 60th minute of surgery and in the recovery. Method of measurement: Pulse oximetry. Body temperature (Celsius degree). Timepoint: Before surgery, 15th minute of surgery, 30th minute of surgery, 45th minute of surgery, 60th minute of surgery and in the recovery. Method of measurement: Mercury thermometer. End-Tidal Carbon dioxide level (mm Hg). Timepoint: Before surgery, 15th minute of surgery, 30th minute of surgery, 45th minute of surgery, 60th minute of surgery and in the recovery. Method of measurement: Capnography. Esfahan University of Medical Sciences Approved 2015-05-29 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)