Evaluation of the effect of dexmedetomedine as a adjuvant drug for local anesthesia infiltration on the rate of interaoperative bleeding and pain relief after septorhinoplasty

Evaluation the effects of dexmedetomidine, as an adjuvant to local anesthesia in rhinoplasty, on intraoperative bleeding and postoperative pain

Randomized double-blind phase 3 clinical trial on 42 patients, with block randomization

This double-blind randomized clinical trial will be conducted in 2023 in Amir Alam Hospital. The randomization method in this study is the use of blocks, and patients are randomized in a ratio of 1:1 in this study. Patients will be divided into two groups receiving dexmedetomidine/not receiving dexmedetomidine.

The criteria for inclusion in the study are patients between 18 and 65 years of age who undergo elective septorhinoplasty surgery and do not have any history of coagulopathy or opioid drug use in the 2 months before the surgery, and patients who have a history of allergy to the study drugs, patients with heart block or chronic heart failure, high blood pressure, kidney and liver disorders, pregnancy, alcohol consumption, and diabetes will be excluded from the study.

Patients who are scheduled for general anesthesia in septorhinoplasty are divided into two groups. The control group will include patients who will be given 8 ml of 2% lidocaine, 1 ml of adrenaline with a dilution of 1:100,000, and 1 ml of normal saline for local anesthesia, and in the intervention group, 8 ml 2% lidocaine, one milliliter of adrenaline with a dilution of 1:100,000, and one milliliter of dexmedetomidine will be used.

The length of time remaining in recovery, the amount of pain and agitation after surgery, the amount of bleeding after surgery, the need for opioid analgesics, the satisfaction of patients one week after surgery.

In this study, we will use the block randomization method. Blocking is usually used to balance the number of samples assigned to each study group. The size of all the blocks in this study is equal, and we will have a 4-person block size (two interventions and two controls). Random allocation software is also used as the randomization tool. The allocation concealment will be used for hiding so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences, each of the random sequences created is recorded on a card, and the cards are placed in the envelopes, respectively. To maintain a random series, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order, and the assigned group of the participant is revealed.

Each group will have a specific code and patients, outcome assessor, and data analyzer will not be informed of the intervention.

All Deidentified Individual Participant Data Set will be available after the end of the study

6 months after publishing the results

Researchers who work in an academic institute

Data is given to the researchers just for assessment and not for interfering

Through email: rezapurrokni@yahoo.com

The data will given to researchers after assessing the eligibility through email