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IRCT20160307026950N15 IRCT 2019-07-24 Esfahan University of Medical Sciences The effects of two different doses dexmedetomidine after Endotracheal intubation Comparison of the effects of two different doses intranasal Dexmedetomidine on heart rate and blood pressure changes after Laryngoscopy and Endotracheal intubation in patients need of anesthesia before surgery 2018-03-21 anticipated 90 Complete https://irct.ir/trial/39269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to three groups A, B, C using the Random Allocation computer software, Blinding description: The drug and placebo are prepared in one form and in the form of a volume in the syringe by the researcher, and the hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the evaluator and data analyser do not understand the type of medication and the investigator deciphers the codes after data analysis. 3 Condition 1: Blood pressure. Condition 2: Heart rate. Intervention 1: Intervention group A:Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group A, 1μg∙kg-1 of intranasal dexmedetomidine is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded . Intervention 2: Intervention group B:Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group B, 2μg∙kg-1 of intranasal dexmedetomidine is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded . Intervention 3: Control group: Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group C, normal saline is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded . 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 no more information
public Amir Mohammad Ataie
Hasht Behesht Building, Amin Alley, Bagh-e-Goldaste Street
Isfahan Iran (Islamic Republic of) 8145845197 +98 31 3222 8461 amir.ataie17@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Hezar Jarib Street
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients candidate Laryngoscopy and Endotracheal intubation Patients older than 18 yeras old and younger than 65 years old Patients with American society of anesthesiology physical status class 1,2 (ASAI,II) 18 years 65 years Both Head and neck masses Airway malformation Uncontrollable blood pressure(More than 180/110) History of cardiovascular disease History of respiratory disease allergies to the drugs studied Body Mass Index greater than 30(BMI>30) R03.0 R00.0 Elevated blood-pressure reading, without diagnosis of hypertension Tachycardia, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group A:Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group A, 1μg∙kg-1 of intranasal dexmedetomidine is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded . Intervention group B:Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group B, 2μg∙kg-1 of intranasal dexmedetomidine is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded . Control group: Initially , informed consent is obtained from the patients. After placing the patients on the operating bed, inclusion of standard monitoring including pulsoximetr , capnograph, electrocardiograph (ECG) and the vital signs are attached . In group C, normal saline is given 30 minutes before induction of anesthesia inside both nostrils. Median arterial blood pressure, heart rate, systolic blood pressure and diastolic blood pressure at one, three, five and Ten minutes after intubation are recorded . Heart rate changes. Timepoint: Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy. Method of measurement: Heart monitoring. Systolic blood pressure. Timepoint: Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy. Method of measurement: Non invasive blood pressure monitor. Diastolic blood pressure. Timepoint: Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy. Method of measurement: Non invasive blood pressure monitor. Mean arterial pressure. Timepoint: Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy. Method of measurement: Non invasive blood pressure monitor. Oxygen saturation. Timepoint: Before the intervention, 1 ,3, 5, 10 minutes after laryngoscopy. Method of measurement: Percent with pulse oximeter. Recovery time. Timepoint: From the end of surgery to full consciousness. Method of measurement: Minute with using a chornometer. Esfahan University of Medical Sciences Approved 2017-05-28 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib street Isfahan Isfehan Iran (Islamic Republic of)