Comparison of the incidence of laryngospasm after removal of the laryngeal mask airway (LMA) using two methods coated with lidocaine gel and coated with plain lubricant in pediatric patients presenting to the hospital

Comparison of the incidence of laryngospasm after removal of the laryngeal mask airway (LMA) in two methods: coated with lidocaine gel and coated with plain lubricant in children visiting Mofid Children's Hospital in Tehran

A randomized, single-blind, phase 3 clinical trial with a control group, parallel groups, conducted on 60 patients.

This study will be conducted as a single-blind (outcomes assessor blinded) trial on pediatric patients scheduled for elective surgery using a laryngeal mask (LMA) as the method of airway support during the operation at Mofid Hospital in Tehran. In the first group, LMA insertion will be performed using a simple lubricant gel, and in the second group, it will be performed using lidocaine gel. The anesthesia induction method will be the same for both groups and will include 1-2 mg/Kg midazolam, 0.02 mg/Kg fentanyl, 2-5 mcg/Kg propofol, and 0.1-0.2 mg/Kg cisatracurium. Anesthesia maintenance will be achieved using sevoflurane. Intraoperative monitoring will be carried out using routine monitoring including electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and capnography.

Inclusion criteria: American Society of Anesthesiologists (ASA) class one, candidate for surgery with laryngeal airway mask placement, parental consent to participate in the study, child weight between 5 and 20 kilograms. Exclusion criteria: patient unwillingness to participate in the research project.

In the control group, laryngeal airway mask insertion will be performed using simple lubricant gel (Paliz Teb lubricating gel, Iran). In the intervention group, laryngeal airway mask insertion will be performed using lidocaine gel (Xylogel 2%, Sinadaroo, Iran)

Laryngospasm, Cough during recovery, Cough within the first 12 hours

Randomization was performed using permuted block randomization. For this purpose, two treatment groups (A and B) were defined, and possible block arrangements included AB and BA. Random numbers ranging from 0 to 9 were assigned, where numbers 0–4 corresponded to block AB and numbers 5–9 corresponded to block BA. Subsequently, the sequence of blocks was generated by selecting random numbers from a random number table. For instance, if the selected number corresponded to block AB, the first participant assigned to this block received treatment A, and the second participant received treatment B. Participants who met the inclusion criteria and provided informed consent were enrolled sequentially into the study. Each participant was assigned a unique study identification number according to their order of entry into the study, and their treatment group allocation was determined based on the pre-generated randomization list. To mitigate the predictability of group allocation due to small block sizes, the randomization list was generated prior to the commencement of the study by an independent, blinded individual not involved in the treatment team, and larger block sizes were utilized. Allocation concealment was rigorously maintained until the moment of assignment.

the outcome assessor and the statistical data analyst will be blinded to group allocation. For this purpose, patient information will be provided to the outcome assessor and the statistical analyst in a coded format, and they will not have access to information regarding the type of intervention. Data analysis will be conducted solely based on the assigned codes.