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IRCT20141001019359N15 IRCT 2022-11-04 Bojnourd University of Medical Sciences Simultaneous effect of three dexmedetomidine administration methods on hemodynamic responses following laryngoscopy Comparison between three methods of administration Dexmedetomidine on hemodynamic responses to Laryngoscopy and intubation; A Randomized Clinical Trial 2022-11-20 anticipated 120 Complete https://irct.ir/trial/66493 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three intervention groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 8. So that in each block, there are two people in the first group (DIV), two people in the second group (DIN) , two people in the third group (DNE) and two people in forth group (C). After a random sequence was identified in all blocks, cards were written by writing DIV, DIN, DNE and C to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 120 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group, Blinding description: None of the participants in the study will be aware of the randomization list, and in order to conceal the randomization process, the groups will be placed in closed envelopes in the reception area and will be assigned to the eligible individuals who enter the study. Also, in order to blind the patients to the study groups, in addition to the specific intervention of each group, the interventions of other groups will be performed with an equal volume of normal saline. 3 Hemodynamic variables. Intervention 1: Intervention group DIV: In this group, Patients will receive Dexmedetomidine intravenously at a dose of 0.5µ/kg by infusion pump within 40 minutes before induction of anesthesia. Intervention 2: Intervention group DIV: In this group, Patients will receive 1 µg/kg of undiluted form of Dexmedetomidine Intranasally. Intervention 3: Intervention group DNE: This group of patients will receive 1 µg/kg of Dexmedetomidine diluted with 3 to 4 ml of 0.9% normal saline as a Nebulization 40 minutes before anesthesia induction. Intervention 4: Control group: In this group, all interventions that are done for other groups will be performed with normal saline in equal volumes. 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 further information.
public Ali Esmaeili
North Khorasan School of Medicine, Bojnurd, iran
Bojnurd Iran (Islamic Republic of) 9416678894 +98583151 dresmaely8@gmail.com Bojnourd University of Medical Sciences scientific Ali Esmaeili
North Khorasan School of Medicine, Bojnurd, iran
Bojnurd Iran (Islamic Republic of) 9416678894 +98583151 dresmaely8@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) The Patient must be between 20 and 60 years old ASA physical status I-II The Patient must not have any intranasal lesions The patient must not have cardiovascular problems The patient must not have asthma or respiratory illness 20 years 60 years Both Patients who are addictive or have drug abuse Patients with an unanticipated difficult airway. T88.59 Other complications of anesthesia Prevention Prevention Prevention Placebo Intervention group DIV: In this group, Patients will receive Dexmedetomidine intravenously at a dose of 0.5µ/kg by infusion pump within 40 minutes before induction of anesthesia. Intervention group DIV: In this group, Patients will receive 1 µg/kg of undiluted form of Dexmedetomidine Intranasally. Intervention group DNE: This group of patients will receive 1 µg/kg of Dexmedetomidine diluted with 3 to 4 ml of 0.9% normal saline as a Nebulization 40 minutes before anesthesia induction. Control group: In this group, all interventions that are done for other groups will be performed with normal saline in equal volumes. Changes in hemodynamic parameters during intubation. Timepoint: After induction of anesthesia, in the first 5 minutes after intubation, every 1 minute after induction and on minutes 7 and 10. Method of measurement: Using the monitoring device. Hemodynamic responses during skin incision. Timepoint: Skin incision time. Method of measurement: Patients' response to skin incision will be recorded as yes/no (no if less than 20% changes in hemodynamic parameters and yes if more than 20% changes are observed in them). Patient's sedation status. Timepoint: At the entering of the operating room and then 40 minutes after the interventions. Method of measurement: Ramsey's sedation scale. Extubation time after reversal of neuromuscular relaxant. Timepoint: From the time of administration of Neostigmine to removal of the endotracheal tube. Method of measurement: chronometer. Post-operative nausea and vomiting. Timepoint: 2 hours after the operation. Method of measurement: In the form of presence or absence. Sore throat after operation. Timepoint: 2 hours after the operation. Method of measurement: In the form of presence or absence. Bojnourd University of Medical Sciences Approved 2022-10-20 Ethics committee of North Khorasan University of Medical Sciences Vice Chancellor for Research of North Khorasan University of Medical Sciences, Bojnurd Bojnurd North Khorasan Iran (Islamic Republic of)