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IRCT20220424054628N1 IRCT 2022-04-30 Esfahan University of Medical Sciences The effect of dexmedetomidine on cardiovascular response The effect of two different doses of dexmedetomidine intranasal on the cardiovascular response to laryngoscopy and endotracheal intubation 2022-05-21 anticipated 90 Complete https://irct.ir/trial/63124 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Randomization description: In this study, the simple randomization method of block randomization (block randomization) we will use. Blocking is usually in order Balance the number of samples assigned to each group To be used in the study. This feature helps researchers to Items that require intermediate analyzes during the sampling process The number of samples assigned to each of the case groups Study is equal. The size of all the blocks is equal and we are in this We will have a three-group trial of 6 blocks of 15. Randomization tools are also used in sequence generation software Random (software allocation Random) is used that Random sequence generation software in addition to simple randomization capable To generate random sequences by block generation method. For hiding We avoid concealment allocation We use the method used to execute the sequence Random refers to study participants, in a way That before the individual is assigned, the assigned group is not specified. With From opaque envelopes sealed in random sequence (envelopes opaque, sealed, numbered Sequentially) in This method uses each of the random sequences created on a card It is registered and the cards are placed in the letter envelopes in order To be. In order to maintain a random sequence, also on the outer surface of the envelope The numbering is done in the same way. Finally the envelope lid The letters are pasted and placed in a box, respectively. At Time to start registration of participants, based on the order of entry of the company Eligible applicants to open one of the envelopes in order And the assigned group of the participant will be revealed, Blinding description: The researcher, patients and project partner who will perform the statistical analysis will not be aware of the study (triole blind). The grouping of patients will be recorded on a sheet and given to one of the project colleagues. 3 Cardiovascular response after laryngoscopy and tracheal intubation. Intervention 1: Intervention group: 1 µg / kg dexmedetomidine intranasal at a concentration of 100 µg / ml in a 1cc syringe after injection of anesthetic drug. Intervention 2: Intervention group: 2 µg / kg dexmedetomidine intranasal at a concentration of 100 µg / ml in a 1cc syringe after injection of anesthetic drug. Intervention 3: Control group: Normal saline with a volume equivalent to groups 1 and 2 intranasally. Yes - There is a plan to make this available What will be shared: Information on the effectiveness of dexmedetomidine on the cardiovascular response When: Start the access period up to one year after the results are published To whom: Researchers Conditions: Can be used for secondary studies. Where to obtain: Correspond with honarmand@mui.ac.ir. How to obtain: Will be sent after receiving the email. Comments:
public Azim Honarmand
Al-Zahra Hospital, Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square
Isfahan Iran (Islamic Republic of) 8164945811 +98 31 3662 4796 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences scientific Azim Honarmand
Al-Zahra Hospital, Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square
Isfahan Iran (Islamic Republic of) 8164945811 +98 31 3662 4796 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Elective surgery No airway abnormalities Requires endotracheal intubation under general anesthesia 18 years 65 years Both History of allergy to the studied drug Difficult Airway Heart block in ECG BMI>30 History of obstruction of the nasopharyngeal ducts Pregnancy Prevention Prevention Placebo Intervention group: 1 µg / kg dexmedetomidine intranasal at a concentration of 100 µg / ml in a 1cc syringe after injection of anesthetic drug Intervention group: 2 µg / kg dexmedetomidine intranasal at a concentration of 100 µg / ml in a 1cc syringe after injection of anesthetic drug Control group: Normal saline with a volume equivalent to groups 1 and 2 intranasally Heart Rate. Timepoint: before induction of anesthesia and minutes 1, 3, 5, 10. Method of measurement: Cardiac monitor device. Systolic blood pressure. Timepoint: before induction of anesthesia and minutes 1, 3, 5, 10. Method of measurement: In millimeters of mercury using a calibrated barometer. Diastolic blood pressure. Timepoint: before induction of anesthesia and minutes 1, 3, 5, 10. Method of measurement: In millimeters of mercury using a calibrated barometer. Mean arterial pressure. Timepoint: before induction of anesthesia and minutes 1, 3, 5, 10. Method of measurement: In millimeters of mercury using a calibrated barometer. Percentage of oxygen saturation. Timepoint: before induction of anesthesia and minutes 1, 3, 5, 10. Method of measurement: Pulse oximeter. Hypotension. Timepoint: Before induction of anesthesia, minutes 1, 3, 5, 10. Method of measurement: In millimeters of mercury using a calibrated barometer. Hypertension. Timepoint: Before induction of anesthesia, minutes 1, 3, 5, 10. Method of measurement: In millimeters of mercury using a calibrated barometer. Bradycardia. Timepoint: Before induction of anesthesia, minutes 1, 3, 5, 10. Method of measurement: Cardiac monitor device. Tachycardia. Timepoint: Before induction of anesthesia, minutes 1, 3, 5, 10. Method of measurement: Cardiac monitor device. Esfahan University of Medical Sciences Approved 2022-01-17 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square Isfahan Isfehan Iran (Islamic Republic of)