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

The purpose of this study is to compare the effects of Propofol and Isoflurane on the level of blood glucose in patients with type 2 diabetes mellitus who are surgical candidates.

This clinical trial is randomized, without any control group, community-based, and pragmatic, with parallel groups and triple blind.

Participants would be selected according to the order of referral to the surgical centers after evaluating the inclusion and exclusion criteria and randomly divided into Isoflurane or Propofol receiving group. After obtaining the full profile, vital signs, blood glucose level, and the oxygen and CO2 levels of the blood will be recorded before, during and after the surgery up to one hour.

Presence of type 2 diabetes mellitus, Being a candidate for an elective surgery with general anesthesia, A duration of more than one hour for the surgical operation

The participants of the first group (Isoflurane) would be first anesthetized with Fentanyl, Atracurium and Thiopental sodium. Isoflurane 1-1.5% in a mixture of 50% oxygen and nitrous oxide (N2O) would be used for anesthetic maintenance. In the second group (Propofol), induction of anesthesia will be performed in patients with Fentanyl, Atracurium and Propofol. Propofol will be used at a rate of 9 to 12 milligrams per kilogram of body weight per hour for anesthetic maintenance. Moreover, within an interval (prior to the surgery and up to one hour after surgery), vital signs, blood oxygen and blood glucose levels would be evaluated.

Blood glucose levels in patients before and after surgery in milligrams per deciliter

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.

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.