The Effect of Ketamine in Treatment of COPD exacerbatio

Phase 3

Recruiting

Conditions: Chronic Obstructive Pulmonary Disease Exacerbation (COPD exacerbation).
Chronic obstructive pulmonary disease with (acute) exacerbation
J44.1

Registration Number: IRCT20200809048341N3

Lead Sponsor: Yazd University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.