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IRCT20190928044907N2 IRCT 2021-05-02 Babol University of Medical Sciences The effect of oral Tramadol in prevention and treatment of shivering during and after surgery The effect of oral Tramadol in prevention and treatment of Intra & post-operative shivering in inguinal surgery by spinal anesthesia 2021-05-05 anticipated 200 Complete https://irct.ir/trial/55104 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, a simple random method with individual units will be used. The patients are divided into two groups of 100 intervention and control using a table of random numbers generated by SPSS. The table of numbers produced will be available only to the statistician, and the researcher, clinical caregiver, and patient will not be aware of the contents of the medication package. If the patient enters the intervention group, they will receive a packet of medicine and if he enters the control group, they will receive a placebo. Medication Envelope and Tablet The drug or placebo is exactly the same in shape, size, envelope size, and pill size, and only the random numbers on the envelope are written on them. Neither the physician nor the patient knows which patient is receiving medication or placebo based on random numbers on each envelope. Only a statistician can access the random number table to find out which patient has received medication or placebo, Blinding description: In this study, only the statistician knows the contents of the drug or placebo package, and researchers, patients, and clinical caregivers are blind to the data and prescription of the drug or placebo. After explaining to patients and obtaining informed consent, they will be explained that they may be in any of the groups receiving medication or placebo. The selection of patients to be in the group of receiving medication or placebo will be done by random software and random numbers, which is done by a statistician. The statistics expert has provided 100 envelopes containing unnamed and randomly numbered drugs, and 100 envelopes containing placebo and encoded with random numbers. The medicine and the pharmacopoeia and their packaging will be completely similar in shape, color and size. Anesthesiologists and health care providers in the operating room are blind to the contents of the envelope for medication or placebo, and only after entering the envelope code in the data collection form, they prescribe the contents to the patient, followed by cardiovascular and respiratory monitoring of all patients equally. 3 peri operative shivering. Intervention 1: Intervention group: Patients receiving the drug receive a 50 mg tablet of oral tramadol made by Caspian Pharmaceutical Company, single dose and 2 hours before the start of elective surgery in the inguinal area by spinal anesthesia. Intervention 2: Control group: Patients receiving placebo, receiving vitamin supplement in the form of 1 mg tablets of oral folic acid, made by Rooz Daroo Pharmaceutical Company, are single dose and 2 hours before the start of elective surgery in the inguinal area by spinal anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Seyed Hossein Hamidi M.D.
Ganj Afrooz St., Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3223 8301 a.hamidi@mubabol.ac.ir Babol University of Medical Sciences scientific Seyed Hossein Hamidi M.D.
Ganj Afrooz St., Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3223 8301 a.hamidi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Age range 18 to 70 years Classes one and two ASA Elective surgery Inguinal surgery Spinal anesthesia non opium addict 18 years 70 years Both Patient refuse to spinal anesthesia Clinical ASA class three or more Emergency surgery indications Any substance addiction History of allergies to tramadol or other Opiates History of preoperative shivering History of respiratory depression R68.83 Chills (without fever) Treatment - Drugs Treatment - Drugs Intervention group: Patients receiving the drug receive a 50 mg tablet of oral tramadol made by Caspian Pharmaceutical Company, single dose and 2 hours before the start of elective surgery in the inguinal area by spinal anesthesia. Control group: Patients receiving placebo, receiving vitamin supplement in the form of 1 mg tablets of oral folic acid, made by Rooz Daroo Pharmaceutical Company, are single dose and 2 hours before the start of elective surgery in the inguinal area by spinal anesthesia. Shivering during and after surgery. Timepoint: At beginning, 5، 10، 15، 20، 30، 45، 60، 75، 90، 120 minutes after beginning of surgery. Method of measurement: Researcher's observation for the incidence and severity of shivering based on a comparison of Crassell ratings. Babol University of Medical Sciences Approved 2020-11-14 Ethics Committee of Babol University of Medical Sciences Ganj Afrooz St., University Square Babol Mazandaran Iran (Islamic Republic of)