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IRCT20090129001615N8 IRCT 2023-05-13 Esfahan University of Medical Sciences Investigating the effective dose of dexmedetomidine in preventing cough during extubation Investigating the preventive effect of two different doses of dexmedetomidine on the incidence of cough and respiratory complications during extubation compared to the control group. 2023-05-22 anticipated 105 Complete https://irct.ir/trial/69766 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random allocation software, patients are divided into three groups, Blinding description: The study participants, the person who collects the data, and the data analyst are not aware of the study groups. 2-3 respiratory complications during extubation. Intervention 1: Intervention group 1: 0.5 μg/kg of dexmedetomidine is injected as a bolus and then 0.3 μg/kg of dexmedetomidine is injected as an infusion, ten minutes before the endotracheal tube is removed. Intervention 2: Intervention group2: 0.5 μg/kg of dexmedetomidine is injected as a bolus and then 0.5 μg/kg of dexmedetomidine is injected as an infusion, ten minutes before the endotracheal tube is removed. Intervention 3: Control group: 10 minutes before remove the tracheal tube, normal saline is injected with an equal volume of groups 1 & 2 as a bolus and then with an equal volume of the other two groups as an infusion. It is necessary to explain that if a patient in this group has a continuous cough, tachycardia with heart rate above 100 times per minute, blood pressure increase to systolic pressure above 140 and diastolic pressure above 90 mm Hg, lidocaine with a dose of 1.5 mg/kg is used for control, if there is no response to lidocaine fentanyl It is injected at a dose of 2 μg/kg. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Azim Honarmand
Shohada Soffeh Street., Alzahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 1992 Honarmand@med.mui.ac.ir Esfahan University of Medical Sciences scientific Azim Honarmand
Shohada Soffeh Street., Alzahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 1992 Honarmand@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years ASA1,2 need general anesthesia with tracheal intubation 18 years 65 years Both Patients with heart failure Patients with respiratory failure Patients with renal failure Patients with hepatic failure Previous known allergy to study drugs heart block Uncontrolled blood pressure smokers Addiction to any type of addictive substance Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: 0.5 μg/kg of dexmedetomidine is injected as a bolus and then 0.3 μg/kg of dexmedetomidine is injected as an infusion, ten minutes before the endotracheal tube is removed. Intervention group2: 0.5 μg/kg of dexmedetomidine is injected as a bolus and then 0.5 μg/kg of dexmedetomidine is injected as an infusion, ten minutes before the endotracheal tube is removed. Control group: 10 minutes before remove the tracheal tube, normal saline is injected with an equal volume of groups 1 & 2 as a bolus and then with an equal volume of the other two groups as an infusion. It is necessary to explain that if a patient in this group has a continuous cough, tachycardia with heart rate above 100 times per minute, blood pressure increase to systolic pressure above 140 and diastolic pressure above 90 mm Hg, lidocaine with a dose of 1.5 mg/kg is used for control, if there is no response to lidocaine fentanyl It is injected at a dose of 2 μg/kg Frequency of coughing during extubation. Timepoint: From the time of full awakening to 5 minutes after extubation. Method of measurement: Using direct observation, the occurrence or non-occurrence of cough is recorded. Severity of cough. Timepoint: From the time of full awakening to 5 minutes after extubation. Method of measurement: Minogue scale. Determination and comparison of systolic blood pressure in three groups. Timepoint: 5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery. Method of measurement: Dial sphygmomanometer. Determination and comparison of diastolic blood pressure in three groups. Timepoint: 5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery. Method of measurement: Dial sphygmomanometer. Determination and comparison of mean arterial pressure in three groups. Timepoint: 5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery. Method of measurement: Dial sphygmomanometer. Determination and comparison of heart rate in three groups. Timepoint: 5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery. Method of measurement: pulse oximeter. Determination and comparison of respiratory rate in three groups. Timepoint: 5 minutes before the end of surgery, at the end of surgery, at the time of awakening, at the time of extubation, 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery. Method of measurement: observation. Determining and comparing the average dose of lidocaine and fentanyl used to control cough. Timepoint: From the time of full awakening to 5 minutes after extubation. Method of measurement: observation. Determining and comparing the average dose of labetalol used in three groups. Timepoint: From the time of full awakening to 5 minutes after extubation. Method of measurement: observation. Determining and comparing the average duration of surgery and anesthesia and stay in recovery in three groups. Timepoint: From the beginning of surgery to exit from recovery. Method of measurement: observation. Determining and comparing the average dose of ondansetron consumed in three groups. Timepoint: From the time of full awakening to 5 minutes after extubation. Method of measurement: observation. Determination and comparison of pain intensity in three groups. Timepoint: Every 15 minutes in recovery until leaving it. Method of measurement: Visual Analogue Scale. Determining and comparing the frequency of nausea and vomiting in three groups. Timepoint: Every 15 minutes in recovery until leaving it. Method of measurement: observation. Determining and comparing the average duration of extubation in three groups. Timepoint: At the time of extubation. Method of measurement: observation. Determining and comparing the average level of consciousness in three groups. Timepoint: at 2 minutes and 5 minutes after extubation, at the time of entering recovery and 10 minutes after recovery. Method of measurement: Using a 4-point scale, 0=sleepy and unresponsive 1=sleepy but can be woken up 2=sleepy but opens eyes with voice command 3=fully alert. Esfahan University of Medical Sciences Approved 2023-04-16 Ethics committee of Isfahan University of Medical Sciences Hezar jarib Ave., Isfahan university of medical sciencies Isfahan Isfehan Iran (Islamic Republic of)