Comparison between three methods of administration Dexmedetomidine on hemodynamic responses to Laryngoscopy and intubation; A Randomized Clinical Trial

Comparison between three methods of administration dexmedetomidine on hemodynamic responses to laryngoscopy and intubation

Double-Blind Randomized Clinical Trial, Phase 3 on 120 patients, Web-based randomization software was used for randomization.

The present study will be conducted in the context of Reduction of hemodynamic changes in 120 patients aged 20-60 years who are candidates for surgery at Imam Ali Hospital. Patients are divided into four groups in a blocked random allocation using the web-based system. Hemodynamic evaluation of patients will be done by heart monitoring tool, in the first 5 minutes after intubation, every 1 minute and then in minutes of 7 and 10. for blinding, the patients, the surgeon, and the person performing the evaluation at different intervals will be blinded to the groups.

Inclusion criteria: Be candidate for surgery under general anesthesia. Do not have respiratory diseases. The patient must not have any intranasal lesions. Do not have heart diseases. Exclusion criteria: Do not be allergic to the drugs in the study. The patient has an unanticipated difficult airway.

The first group (DIV group): In this group, patients will receive dexmedetomidine intravenously at a dose of 0.5µ/kg by infusion pump before induction of anesthesia. The second group (DIN group): in this group, the patients will receive dexmedetomidine in the amount of 1 µg/kg intranasally. The third group (DNE): In this group, patients will receive 1 µg/kg of dexmedetomidine diluted with 3 to 4 ml of 0.9% normal saline before induction of anesthesia in the form of nebulization. The fourth group (control group): In this group, all the interventions that are done for other groups will be performed with normal saline in equal volumes.

hemodynamic changes

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.

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.