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IRCT20200809048341N3 IRCT 2024-01-20 Yazd University of Medical Sciences The Effect of Ketamine in Treatment of COPD exacerbation The Effect of Nebulized Ketamine in Treatment of Patients with Chronic Obstructive Pulmonary Disease Exacerbation (COPD exacerbation) 2023-03-21 anticipated 80 Complete https://irct.ir/trial/73829 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From all patients with COPD who refer to the emergency department of Shahid Rahmonun and Shahid Sadouqi hospitals with moderate or severe exacerbation of symptoms, according to the entry and exit criteria, 80 people are included in the study and are divided into two intervention and placebo groups using a random number table. Tables of random numbers are prepared by computers that arrange numbers randomly, which are divided into blocks of five digits to facilitate its use. In this method, the community members are numbered from 1 to 80, then a row and a column of the table are randomly selected. The intersection point of the selected row and column is the starting point of sampling. (choose the point by closing eyes, placing finger or pen tip on the table). and only pays attention to and selects the smaller numbers. From this point, a plus or a cross is drawn. All the numbers that are added or crossed over are selected as members of the sample. This process continues until the required sample (40 cases) is selected, Blinding description: The method of blinding was that a sheet with A and B written on it was placed in the envelopes. The evaluating doctor held these closed envelopes in front of the patient and asked them to choose one and without looking inside the envelope, he gave it to the relevant nurse, so that according to whether it was A or B inside the envelope, he would prescribe the medicine for the patient. The evaluating doctor did not know the type of medicine received by the patient. With this method, the patient did not know the type of treatment. 3 Chronic Obstructive Pulmonary Disease Exacerbation (COPD exacerbation). Intervention 1: Intervention Group: In addition to standard treatment, they receive ketamine nebulizer with a dose of 0.5 mg per weight and a maximum of 25 mg. After 20 minutes, if the symptoms do not improve, the above method is repeated again. Intervention 2: ontrol Group: receives the main treatment with a standard dose (nebulizer 2.5 mg of albuterol and 5 mg of Atrovent and intravenous injection of methylprednisolone 1 mg per weight and oxygen with Venturi mask) along with nebulizer placebo (saline). Yes - There is a plan to make this available What will be shared: . When: . To whom: . Conditions: . Where to obtain: . How to obtain: . Comments:
public Golnaz Samadzadeh Yazdi
Termeh dead end, Fazilat St., Student Square
Yazd Iran (Islamic Republic of) 8915151875 +98 35 3821 6033 G.samadzadeh.2020@gmail.com Yazd University of Medical Sciences scientific Golnaz Samadzadeh Yazdi
Termeh dead end, Fazilat St., Student Square
Yazd Iran (Islamic Republic of) 8915151875 +98 35 3821 6033 G.samadzadeh.2020@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged 16 to 60 years with moderate to severe COPD who refer to the emergency room of Shahid Rahmonun and Shahid Sadoughi hospitals and do not meet the exclusion criteria. 18 years 60 years Both Patients under 16 and over 60 years old Heart, kidney, liver failure Patients with heart diseases such as arrhythmia, ischemic heart diseases, etc. Oral fever above 38.3 degrees Celsius Low blood pressure (diastolic blood pressure less than 90 mm Hg) or high blood pressure (systolic blood pressure more than 180 mm Hg) glaucoma Decreased level of consciousness, brain tumor, suspicion of increased intracranial pressure (ICP) for any reason, psychosis, history of seizures and other brain disorders... Suspicion of other respiratory diseases such as pneumonia, pneumothorax, pulmonary embolism, pulmonary edema, etc. Inability to use peak expiratory flow meter Severe respiratory distress requiring intubation or NIV Pregnancy Known allergy to ketamine. J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Drugs Placebo Intervention Group: In addition to standard treatment, they receive ketamine nebulizer with a dose of 0.5 mg per weight and a maximum of 25 mg. After 20 minutes, if the symptoms do not improve, the above method is repeated again. ontrol Group: receives the main treatment with a standard dose (nebulizer 2.5 mg of albuterol and 5 mg of Atrovent and intravenous injection of methylprednisolone 1 mg per weight and oxygen with Venturi mask) along with nebulizer placebo (saline). Peak expiratory flow rate (PEFR) improvement. Timepoint: Upon arrival, 60 minutes later, 4 hours later. Method of measurement: By the peak flow monitor, after taking a deep breath, the patient blows into the device 3 times with maximum speed and power, and the best one is selected for study. Increase Arterial O2 Saturation(SaO2). Timepoint: Upon arrival, 20, 40, 60 ,90 , 120 minutes later, 4 hours later. Method of measurement: By pulse oximeter. Decrease pulse rate and respiratory rate. Timepoint: Upon arrival, 20, 40, 60 ,90 , 120 minutes later, 4 hours later. Method of measurement: By monitoring device. Improvement of dyspnea severity score. Timepoint: Upon arrival, 20, 40, 60 ,90 , 120 minutes later, 4 hours later. Method of measurement: Based on the modified Borg dyspnea scale, the patient scored the severity of her/his dyspnea from 0 to 10. The need for hospitalization. Timepoint: On arrival, 60 minutes and 4 hours later. Method of measurement: Based on the clinical symptoms and severity of the patient's dyspnea. The need for a second dose of the drug. Timepoint: On arrival, 60 minutes and 4 hours later. Method of measurement: Based on the clinical symptoms and severity of the patient's dyspnea. The extent of the need to start rescue medication. Timepoint: On arrival, 60 minutes and 4 hours later. Method of measurement: Based on the clinical symptoms and severity of the patient's dyspnea. Yazd University of Medical Sciences Approved 2020-05-11 Ethics committee of School of Medicine _ Shahid Sadoughi University of Medical Sciences Central building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd Yazd Yazd Iran (Islamic Republic of)