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IRCT20190131042569N2 IRCT 2020-02-14 Research Department of Shahid Beheshti University of Medical Sciences The effect of Magnesium Sulfate and Ketamine gargle on postoperative sore throat in patient with prone position. Comparison of the effectiveness of Magnesium Sulfate and Ketamine gargle on postoperative sore throat in patient with prone position during Laminectomy surgery. 2020-01-15 anticipated 60 Complete https://irct.ir/trial/45121 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Each patient who qualify for inclusion after completing the consent form is assigned by the person in charge of this process using a random number table from 1 to 60( 1- 20 Ketamine group, 21-40 Magnesium Sulfate group, 41-60 control group ) where the person is placed on one of the numbers and assigned to one of the 3 specified groups. (Simple randomization by individual using random number table), Blinding description: The anesthesiologist in charge of anesthesia is not aware of the patient's group (intervention or control groups) whom receive anesthesia. And the person responsible for follow-up and recordings data and pain levels has no information about the intervention or control group and only one person responsible for giving the patient's drug or placebo is aware of the patient groups. 3 Throat pain after intubation. Intervention 1: Intervention group1: Ketamine group: 1 mg/kg ketamine(Rotexmedica company) plus 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction. Intervention 2: Intervention group2: Magnesium sulfate group: 30 mg/kg Magnesium sulfate(Pasteur Institute) plus 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction. Intervention 3: Control group: 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction. Yes - There is a plan to make this available What will be shared: Participant data (age, pain severity and type of patient's group) are to be shared. When: 1 year after publication To whom: Researchers working in academic institutions Conditions: Using data and analysis for use in academic research Where to obtain: Send Email Dr.Nima Saeedi Email Address: nimasaeedi7@yahoo.com How to obtain: Send request via Email and after 1 week will be replied. Comments:
public Nima Saeedi
No. 11, First East Ave., Bistochahar metri Ave., Tehran., Iran
Tehran Iran (Islamic Republic of) 1997778416 +98 21 2641 8939 nimasaeedi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Nima Saeedi
No. 11, First East Ave., Bistochahar metri Ave., Tehran., Iran
Tehran Iran (Islamic Republic of) 1997778416 +98 21 2641 8939 nimasaeedi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients between 30-70 years old candidate for Laminectomy surgery 30 years 70 years Both History of Hypertension or cardiac disease Upper Respiratory Airway Infection Cleft lip or palate Arrhythmia Cardiac conduction disorder R07.0 Pain in throat Prevention Prevention Placebo Intervention group1: Ketamine group: 1 mg/kg ketamine(Rotexmedica company) plus 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction. Intervention group2: Magnesium sulfate group: 30 mg/kg Magnesium sulfate(Pasteur Institute) plus 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction. Control group: 30cc dextrose 5% gargled by patient for 30 seconds 15 minutes before induction. Post operation throat pain. Timepoint: Upon arrival to recovery, 2,12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Research Department of Shahid Beheshti University of Medical Sciences Approved 2020-01-12 Ethics committee Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Science, Arabi Ave., Daneshjoo Blvd., Velenjak, Tehran. Tehran Tehran Iran (Islamic Republic of)