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IRCT20141127020112N10 IRCT 2019-09-02 Iran University of Medical Sciences Effect of transtracheal lidocaine and intravenous lidocaine on hemodynamic of Patients Comparison the effect of transtracheal lidocaine and intravenous lidocaine on hemodynamic of Patients with hypertension undergoing drug treatment to tracheal intubation 2017-03-21 anticipated 82 Complete https://irct.ir/trial/41497 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomly divided into intervention and control groups using a lottery method. As the names of all participants are placed inside the container. The names are drawn out from the container, respectively, and placed in the intervention and control groups. At the end, the papers containing the names are opened and different groups are determined, Blinding description: Participants and outcome evaluators were not aware of the intervention. 3 Hemodynamic changes in patients with hypertension. Intervention 1: Intervention group 1: In group A, fentanyl 2 mg/kg and intravenous lidocaine 2% 1.5mg/ kg was injected and anesthetized by thiopental 4 mg/kg and cisatracurium 0.2 mg/kg. Then, 30 seconds after the induction, blood pressure and heart rate were recorded After 4 minutes, the patient was intubated by an appropriate tracheal tube and 30 seconds after the intubation, blood pressure and heart rate were recorded again, and then, at minutes 3, 6 and 9 after intubation, the patient's blood pressure and heart rate were recorded. In all monitoring registers, any incidence of dysrhythmia was recorded in the ECG. Intervention 2: Intervention group 2: In the group B, fentanyl 2 mg/kg was injected intravenously and anesthetized by thiopental 4 mg/kg and cisatracurium 0.2 mg/kg. Then, 30 seconds after the induction, blood pressure and heart rate were recorded and lidocaine 2% 1.5mg/ kg was injected as transtracheal. After 4 minutes, the patient was intubated by an appropriate tracheal tube and, similar to group A, at specified times, blood pressure and heart rate were recorded. Lidocaine was injected in the both ways 90 seconds before intubation. Intervention 3: Control group: In the group C, the only difference with other groups was the lack of use of lidocaine. Yes - There is a plan to make this available What will be shared: All individual data of the participants in this study will be shared after unidentifiable individuals When: The access period will start from 1398 to 1400 To whom: Data will be available to researchers working in the university. Conditions: Just for performing research Where to obtain: Refer to the responsible person for accessing the data How to obtain: The data will be available one month after the responsible person's approval Comments:
public Pooya Derakhshan
Hazrate Rasoole Akram hospital,Niayesh St,Satarkhan Av
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 1444 pooya_derakhshan@bums.ac.ir Iran University of Medical Sciences scientific Pooya Derakhshan
Hazrate Rasoole Akram hospital,Niayesh St,Satarkhan Av
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6435 1444 pooya_derakhshan@bums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with American Society of Anesthesiologists (ASA) grade 3 and lower 40 years 70 years Both Emergency surgery Drug abuse Alcohol consumption All cases of difficult intubation Diabetes Heart failure Kidney failure Taking beta blocker Primary dysrhythmia Systolic pressure more than 170 mmHg Diastolic more than 100 mmHg I10 Essential (primary) hypertension Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: In group A, fentanyl 2 mg/kg and intravenous lidocaine 2% 1.5mg/ kg was injected and anesthetized by thiopental 4 mg/kg and cisatracurium 0.2 mg/kg. Then, 30 seconds after the induction, blood pressure and heart rate were recorded After 4 minutes, the patient was intubated by an appropriate tracheal tube and 30 seconds after the intubation, blood pressure and heart rate were recorded again, and then, at minutes 3, 6 and 9 after intubation, the patient's blood pressure and heart rate were recorded. In all monitoring registers, any incidence of dysrhythmia was recorded in the ECG. Intervention group 2: In the group B, fentanyl 2 mg/kg was injected intravenously and anesthetized by thiopental 4 mg/kg and cisatracurium 0.2 mg/kg. Then, 30 seconds after the induction, blood pressure and heart rate were recorded and lidocaine 2% 1.5mg/ kg was injected as transtracheal. After 4 minutes, the patient was intubated by an appropriate tracheal tube and, similar to group A, at specified times, blood pressure and heart rate were recorded. Lidocaine was injected in the both ways 90 seconds before intubation. Control group: In the group C, the only difference with other groups was the lack of use of lidocaine. Blood pressure. Timepoint: After 4 minutes, patients with appropriate endotracheal tube and 30 seconds after intubation were recorded, at 3, 6 and 9 minutes after intubation, blood pressure and heart rate. Method of measurement: Mercury barometer. Heart rate. Timepoint: After 4 minutes, patients with appropriate endotracheal tube and 30 seconds after intubation were recorded, at 3, 6 and 9 minutes after intubation, blood pressure and heart rate. Method of measurement: Mercury barometer. Iran University of Medical Sciences Approved 2018-09-23 Ethics committee of Iran University of Medical Sciences Next to Milad Tower, Hemat Highway ,Tehran Tehran Tehran Iran (Islamic Republic of)