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IRCT20200825048515N55 IRCT 2022-06-21 Esfahan University of Medical Sciences Effect of different doses of ketamine on prevention of fentanyl induced coughing Effect of different doses of ketamine on prevention of fentanyl induced coughing during general anesthesia induction 2022-07-22 anticipated 56 Complete https://irct.ir/trial/64112 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 56 eligible patients are randomly selected. For this, the letter A is written on 14 sheets, the letter B is written on 14 sheets, the letter C is written on 14 sheets, and the letter D is written on 14 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups, Blinding description: In order to achieve the triple-blind study, different doses of Ketamine and placebo will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, C, and D. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Candidate patients for surgery under general anesthesia using fentanyl. Intervention 1: Intervention group 1: Patients in this group receive ketamine at a dose of 0.15 mg / kg intravenously within 10 seconds, one minute before fentanyl injection. Intervention 2: Intervention group 2: Patients in this group receive ketamine at a dose of 0.20 mg / kg intravenously within 10 seconds, one minute before fentanyl injection. Intervention 3: Intervention group 3: Patients in this group receive ketamine at a dose of 0.25 mg / kg intravenously within 10 seconds one minute before fentanyl injection. Intervention 4: Control group: Patients in this group receive normal saline at a dose of 0.20 mg / kg intravenously within 10 seconds one minute before fentanyl injection. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Azim Honarmand
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 honarmand@med.mui.a.ir Esfahan University of Medical Sciences scientific Azim Honarmand
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 honarmand@med.mui.a.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age category 65-18 years Candidate for surgery under general anesthesia using fentanyl American Society of Anesthesiologists (ASA) I or II Satisfaction to participate in the study 18 years 65 years Both Underlying diseases (including heart failure, respiratory, liver, kidney, myocardial ischemic disease, myocardial infarction, hypertension above 140/90 mm Hg, tachycardia (heart rate above 100 beats per minute), depression, asthma, chronic cough) History of allergy to the studied drugs Smoking, addiction Having an upper respiratory infection within the last month Use of drugs such as angiotensin converting enzyme inhibitors (ACEIs), antidepressants (over the past two weeks), and steroids (over the past two weeks) that interfere with the study Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Patients in this group receive ketamine at a dose of 0.15 mg / kg intravenously within 10 seconds, one minute before fentanyl injection. Intervention group 2: Patients in this group receive ketamine at a dose of 0.20 mg / kg intravenously within 10 seconds, one minute before fentanyl injection. Intervention group 3: Patients in this group receive ketamine at a dose of 0.25 mg / kg intravenously within 10 seconds one minute before fentanyl injection. Control group: Patients in this group receive normal saline at a dose of 0.20 mg / kg intravenously within 10 seconds one minute before fentanyl injection. Intensity of cough. Timepoint: Every 3 minutes during induction of anesthesia from the time of drug injection until 10 minutes after endotracheal intubation. Method of measurement: Fentanyl-Induced Cough Scale (FIC). Systolic blood pressure. Timepoint: Every 3 minutes during induction of anesthesia from the time of drug injection until 10 minutes after endotracheal intubation. Method of measurement: Monitoring device. Diastolic blood pressure. Timepoint: Every 3 minutes during induction of anesthesia from the time of drug injection until 10 minutes after endotracheal intubation. Method of measurement: Monitoring device. Hear rate. Timepoint: Every 3 minutes during induction of anesthesia from the time of drug injection until 10 minutes after endotracheal intubation. Method of measurement: Monitoring device. Oxygen saturation (SPO2). Timepoint: Every 3 minutes during induction of anesthesia from the time of drug injection until 10 minutes after endotracheal intubation. Method of measurement: Monitoring device. Isfahan University of Medical Sciences Approved 2022-05-21 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)