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IRCT20111212008384N9 IRCT 2022-04-24 Mashhad University of Medical Sciences Investigation of the effect of administration of Metformin before surgery on controlling postoperative hyperglycemia in non-diabetic patients Investigation of the effect of administration of Metformin before surgery on controlling postoperative hyperglycemia in non-diabetic patients 2020-03-20 anticipated 176 Complete https://irct.ir/trial/62446 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization has been used. In this method, 44 blocks of 4 are selected through the relevant sites. Then 88 letters A and 88 letters B were prepared. Opaque envelopes were also used for concealment. 176 envelopes were prepared and the letters A and B were placed inside the envelopes, respectively. The envelopes were sealed and given to the patient's recipient. Each patient was given an envelope (in order) at the time of referral, which the patient provided to the physician. The letter A represented the metformin group and the letter B represented the placebo group, Blinding description: Employees who admitted patients and recorded data did not know patients who received metformin or placebo and were unaware of how individuals were assigned to the two study groups. 3 blood suger. Intervention 1: Intervention group: It consisted of 88 patients receiving one metformin tablet (Merck Sante company, France) at a dose of 500 mg half an hour before surgery orally at a time. Blood glucose, creatinine, and BUN were measured before surgery in these patients. Also, immediately after the operation, the creatinine level, BUN, was measured and blood glucose levels were measured at 6-hour intervals and up to 24 hours after the operation. Intervention 2: Control group: It consisted of 88 patients who received one placebo tablet orally half an hour before surgery at a time. Blood glucose, creatinine, and BUN were measured before surgery in these patients. Also, immediately after the operation, the creatinine level, BUN, was measured and blood glucose levels were measured at 6-hour intervals and up to 24 hours after the operation (Faculty of Pharmacy, Mashhad University of Medical Sciences provided us with a similar pill to metformin without any special drug effect as a placebo). Yes - There is a plan to make this available What will be shared: Data can potentially be shared after people are not identified When: The access period starts 6 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions Conditions: After correspondence with the scientific person in charge of the project and after the publication of the article, by preserving the intellectual rights of the authors, it is possible to access the data and perform analysis on the information. Where to obtain: To request data, you can correspond by email to the person in charge of the scientific plan How to obtain: To request data, you can correspond by email to the person in charge of the scientific plan Comments:
public Dr. Arash Peivandi Yazdi
Department of anesthesiology, Imam Reza hospital
مشهد Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 1802 2677 PeivandiA@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Arash Peivandi Yazdi
Department of anesthesiology, Imam Reza hospital
مشهد Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3854 3031 PeivandiA@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Non diabetic patients ASA class I or II Candidate for orthopedic surgery in Imam Reza Hospital of Mashhad during 1399 solar year Ages 18 to 80 years 18 years 80 years Both Prohibitions of metformin use, such as acute or chronic renal failure or injury, or a candidate for diagnostic procedures requiring the administration of a contrast agent before and 5 hours after surgery Dissatisfaction Allergy to metformin Patients with ASA above grade II Drug addicts Uncomplicated surgical complication Forcing to use hemodynamic support drugs at any stage of the study Use non-general anesthesia to perform the procedure Need re-surgical intervention in the first 24 hours Diabetic people Prevention Placebo Intervention group: It consisted of 88 patients receiving one metformin tablet (Merck Sante company, France) at a dose of 500 mg half an hour before surgery orally at a time. Blood glucose, creatinine, and BUN were measured before surgery in these patients. Also, immediately after the operation, the creatinine level, BUN, was measured and blood glucose levels were measured at 6-hour intervals and up to 24 hours after the operation. Control group: It consisted of 88 patients who received one placebo tablet orally half an hour before surgery at a time. Blood glucose, creatinine, and BUN were measured before surgery in these patients. Also, immediately after the operation, the creatinine level, BUN, was measured and blood glucose levels were measured at 6-hour intervals and up to 24 hours after the operation (Faculty of Pharmacy, Mashhad University of Medical Sciences provided us with a similar pill to metformin without any special drug effect as a placebo). Blood suger. Timepoint: after surgery then every 6 hours for 24 hours. Method of measurement: Bs glocometr. Mashhad University of Medical Sciences Approved 2020-05-19 Ethics committee of mashhad University of Medical Sciences Department of anesthesiology, Imam Reza hospital, Shariati Square mashhad Razavi Khorasan Iran (Islamic Republic of)