The effect of two different doses of dexmedetomidine intranasal on the cardiovascular response to laryngoscopy and endotracheal intubation

Determination of the effect of 2 different doses of dexmedetomidine intranasal on cardiovascular response to laryngoscopy and endotracheal intubation

Clinical trial with control group, triple blind, randomized, phase 3 on 90 patients

The study of a triple blind randomized clinical trial with a control group during the years 1401-1400 Will be performed at Al-Zahra Medical Center in Isfahan. The person collecting the information does not know the study group, nor does the statistician Does not know the study group

Inclusion criteria: Age 18-65 years II, I ASA (American Anesthesia Association classification based on patients' physical condition) without airway anomaly, elective surgery Inclusion criteria: History of drug sensitivity, pregnancy, Difficult airway , ECG block, BMI> 30, history of obstruction Nasopharyngeal ducts

Group 1: 1 µg/kg intranasal dexmedetomidine at a concentration of 100 µg/ml in a 1cc syringe after injection of anesthetic drug. Group 2: 2 µg/kg intranasal dexmedetomidine at a concentration of 100 µg/ml in a 1cc syringe after injection of anesthetic drug. Group 3: Normal saline with a volume equivalent to groups 1 and 2 intranasally.

Heart rate, systolic blood pressure, diastolic blood pressure, Mean arterial pressure, percentage of oxygen saturation

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.

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.

Information on the effectiveness of dexmedetomidine on the cardiovascular response

Start the access period up to one year after the results are published

Researchers

Can be used for secondary studies.

Correspond with honarmand@mui.ac.ir.

Will be sent after receiving the email.