Comparing the effectiveness of Lidocaine and Dexmedetomidine on the severity of immediate complications after Tonsillectomy surgery

Investigating the effect of Lidocaine and Dexmedetomidine on the complications of Tonsillectomy

A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 90 patients. Randomized in a simple way using a lottery.

This is a three-blind randomized clinical trial that will be conducted on 90 Tonsillectomy in Al-Zahra Hospital, Isfahan. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients are randomly assigned into groups, in each group the desired intervention is applied and the clinical symptoms of the patient are recorded. The researcher who records the patient's symptoms, the analysts who collect the data analyzed during the study, and the patients did not know the type of intervention applied in each group, so they were all blind.

Inclusion criteria: age 4 to 12 years, class I and II ASA anesthesia, candidate for Tonsillectomy surgery, and consent to participate in the study.Exclusion criteria: the presence of acute respiratory infections, allergy to used drugs, abnormal coagulation tests

10 minutes before anesthesia patients in Intervention group A: receive 1.5 mg/kg lidocaine 2% (manufactured by Aburihan company) intravenously within 10 minutes, followed by an intravenous infusion of 2% lidocaine in 20 ml of normal saline with a dose of 0.25 mg/kg/minute until the end of the operation. Intervention group B: receive 1 Mg/kg Dexmedetomidine (manufactured by Exir company), followed by an intravenous infusion of Dexmedetomidine in 20 ml of normal saline with a dose of 0.5Mg/kg/minute until the end of the operation and in Intervention group C: they receive 20 ml of normal saline as a bolus 10 minutes before anesthesia.

Bleeding rate, airway spasm, hoarseness

This is a simple randomized clinical trial in which patients enter the study groups by lottery; The medicines and placebo are placed in sealed, opaque, and similar form packets coded. Each code is also written on paper, folded, and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box; The pocket with the same number is the intervention that will apply to him. This process continues till the number of patients reaches the desired one.

This is a three-way blind clinical trial; In this way, the researcher who records the patient's symptoms is different from the person who prescribes the drug and has no knowledge of the type of drug and is blind. The analysts who analyze the data collected during the study also know the type of intervention. They don't have it in any group and they are blind. Even though the guardian of patients are included in the study, they do not know the type of intervention and are blind.