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IRCT20200825048515N2 IRCT 2020-09-16 Esfahan University of Medical Sciences The effects of rapid sequence induction and localized laryngeal recurrent nerve block with fentanyl on hemodynamic changes Comparative study of the effects of rapid sequence induction(RSI) intubation and localized laryngeal recurrent nerve block with fentanyl on hemodynamic changes in patients with hemodynamic disorders 2020-09-22 anticipated 70 Complete https://irct.ir/trial/50815 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We randomly select 70 eligible patients. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: In this study, due to the different use of two methods of rapid sequence induction (RSI) and localized laryngeal recurrent nerve block with fentanyl, the emergency medical assistant and the patient are aware of the type of intervention. However, the data collector and data analyst did not know the type of patient grouping. 2-3 Hemodynamic Disorders. Intervention 1: Intervention group: In first group, fentanyl 3 mcg/kg, etomidate 0.3 mg/kg and succinylcholine 1.5 mg/kg will be administered to prevent fasciculation. One minute afterwards, intubation will be performed. Intervention 2: Intervention group: In the second group, localized blockage of laryngeal recurrent nerve and superior laryngeal nerve with fentanyl will be used. For this purpose, first apply topical Xyla-p cream to the skin of the injection sites, and by placing a plastic cover on it, the onset of its effect is shortened and the strength of its effect is increased. Then fentanyl at a dose of 1 μg/kg is slowly injected intravenously 1 to 2 minutes before the onset of topical block. Immediately after that, 2 puffs of 10% lidocaine spray will be administered in the oropharynx. Then blockade of the cricoid region and bilateral laryngeal recurrent nerve will be performed by injection of 2% lidocaine. This causes a cough that distributes and directs the local block. Finally, 2 minutes after the completion of local injection block (5 minutes after local block with oral spray), endotracheal intubation will be performed. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Keihan Golshani
Kashani Street.
Isfahan Iran (Islamic Republic of) 8183983434 +98 31 3233 0091 k_golshani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Keihan Golshani
Kashani Street.
Isfahan Iran (Islamic Republic of) 8183983434 +98 31 3233 0091 k_golshani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Hemodynamic disorder in the form of arterial systolic pressure drop to less than 90 mm Hg The age of over 18 years old and under 65 years old No contraindications to taking succinylcholine ASA I or II A degree of Malampati between I-IV The Consent of the attendant to participate the patient in the study 18 years 65 years Both Chance of difficult intubation (small chin, large tongue, short neck, etc.) A history of throat or tracheal surgery A history of asthma or allergies The presence of infection at the site of the local block Patients with cardiac respiratory arrest who require intubation by Crush method. Patients with hemodynamic disorders who have a history of taking antihypertensive drugs. Treatment - Drugs Treatment - Drugs Intervention group: In first group, fentanyl 3 mcg/kg, etomidate 0.3 mg/kg and succinylcholine 1.5 mg/kg will be administered to prevent fasciculation. One minute afterwards, intubation will be performed. Intervention group: In the second group, localized blockage of laryngeal recurrent nerve and superior laryngeal nerve with fentanyl will be used. For this purpose, first apply topical Xyla-p cream to the skin of the injection sites, and by placing a plastic cover on it, the onset of its effect is shortened and the strength of its effect is increased. Then fentanyl at a dose of 1 μg/kg is slowly injected intravenously 1 to 2 minutes before the onset of topical block. Immediately after that, 2 puffs of 10% lidocaine spray will be administered in the oropharynx. Then blockade of the cricoid region and bilateral laryngeal recurrent nerve will be performed by injection of 2% lidocaine. This causes a cough that distributes and directs the local block. Finally, 2 minutes after the completion of local injection block (5 minutes after local block with oral spray), endotracheal intubation will be performed. Blood Pressure. Timepoint: Before, 5, 10, 20 and 30 minutes after intubation. Method of measurement: Monitoring device. Respiratory rate. Timepoint: Before, 5, 10, 20 and 30 minutes after intubation. Method of measurement: Monitoring device. Pulse rate. Timepoint: Before, 5, 10, 20 and 30 minutes after intubation. Method of measurement: Monitoring device. Oxygen saturation percentage. Timepoint: Before, 5, 10, 20 and 30 minutes after intubation. Method of measurement: Monitoring device. Success in endotracheal intubation. Timepoint: After intubation. Method of measurement: Observation. Incidence of complications. Timepoint: After intubation. Method of measurement: Observation. Isfahan University of Medical Sciences Approved 2020-05-13 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)