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IRCT20211206053291N1 IRCT 2022-02-20 Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran lidocaine effect on extubation The effect of intravenous lidocaine on reducing the complications of endotracheal intubation after cardiac surgery 2022-01-08 anticipated 90 Complete https://irct.ir/trial/61127 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is performed using permuted balanced block (block of four) method. In order to observe concealment and blinding at the same time, the random sequence will be converted into composite codes (not group names) and these codes will be provided to the main researcher in closed envelopes. There is no difference in appearance, volume and type of syringe between the two groups of drugs and placebo During the study, after opening each envelope, a syringe corresponding to that code is given to the patient, Blinding description: Extubating the pt when the patient is calm and breathing slowly with a spontaneous ventilator mode 1.5 mg / weight of 2% intravenous lidocaine is injected intravenously (1.5 cc / weight of syringe containing lidocaine at a dose of 1.5 ml / cc).In the control group, 1.5 cc of normal serum will be injected intravenously in terms of weight at the same time under the same conditions.Syringes containing lidocaine or normal saline will be exactly the same and will be coded by a third party And delivered to the head of the nursing shift randomly based on the number of patients who have the conditions of study and then injected by them to the patient at a specified time.Heart rate, blood pressure and possible arrhythmia are assessed before and during the injection, 5 minutes after the injection, and finally one minute after the endotracheal tube is removed and 10 minutes after it, and are completed in a special form by the patient's responsible nurse. N/A Larangospasm.. Intervention 1: Intervention group: 45 patients who have weaning and extubation conditions for at least 6 to 12 hours after surgery. For this purpose, the patient should have relatively simple heart surgery involving vascular occlusion (CABG) or only single valve surgery. Also dangerous arrhythmia and instability. Cardiac (patients treated with epinephrine or Levofed at doses above 1.1 / macro / kg) and respiratory (po2≤60mmhg or (pco2≥50) are also excluded from our study Our study enters. Intervention 2: Control group: For 45 patients, 1.5 cc/kg of normal intravenous saline will be injected at the same time under the same conditions. Syringes containing lidocaine or normal saline will be exactly the same and will be coded by a third person to the nursing shift randomly based on the number of patients The study is delivered and then injected by the patient at a specific time. 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 more information
public Abdolreza Dayani
Valiasr ave,shahid rajaei cardivascular hospital
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2266 3250 dr.a.dayani@gmail.com Iran University of Medical Sciences scientific Abdolreza Dayani
Valiasr ave,shahid rajaei cardivascular hospital
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2266 3250 dr.a.dayani@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) simple cardiac surgury(CABG or valvular) No history of smoking and drug or alcohol addiction during the last 10 years before surgery No history of any drug or food allergies All patients took beta-blockers around the operation and in the morning No history of lung problems (asthma, COPD, etc.) treated with oral or inhaled drugs 18 years 85 years Both Dangerous arrhythmia during or after surgery Hemodynamic instability including: cardiac instability (patients treated with epinephrine or levofed at doses above 1.1 μg / kg) and respiratory instability (po2≤60mmhg or pco2≥50) during postoperative time Bleeding so much that the patient becomes a candidate for reoperation Injection of lidocaine for any reason after surgery EF drop after surgery Use of ECMO or pump balloons after surgery J95.5 Postprocedural subglottic stenosis Treatment - Drugs Placebo Intervention group: 45 patients who have weaning and extubation conditions for at least 6 to 12 hours after surgery. For this purpose, the patient should have relatively simple heart surgery involving vascular occlusion (CABG) or only single valve surgery. Also dangerous arrhythmia and instability. Cardiac (patients treated with epinephrine or Levofed at doses above 1.1 / macro / kg) and respiratory (po2≤60mmhg or (pco2≥50) are also excluded from our study Our study enters Control group: For 45 patients, 1.5 cc/kg of normal intravenous saline will be injected at the same time under the same conditions. Syringes containing lidocaine or normal saline will be exactly the same and will be coded by a third person to the nursing shift randomly based on the number of patients The study is delivered and then injected by the patient at a specific time Cough occurs after extubation. Timepoint: The onset of cough is assessed before and during injection, 5 minutes after injection, and finally one minute after endotracheal tube removal and 10 minutes after. Method of measurement: The incidence of cough is measured by three criteria of cough, which include: 1- no cough or temporary cough following the exit of the endotracheal tube, 2- incidence of cough by breathing, and 3- persistent cough without respiratory stimulation when the endotracheal tube exits up to 10 minutes later. The questionnaire is mentioned. Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran Approved 2021-12-04 Research Ethics Committees of Rajaie Cardiovascular Medical and Research Center valiasr st,niyayesh highway,shahid rajaei cardiovascular center tehran Tehran Iran (Islamic Republic of)