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IRCT20250116064403N1 IRCT 2026-05-06 Shahid Beheshti University of Medical Sciences Occurrence of laryngospasm in pediatric patients 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 2026-06-22 anticipated 60 Pending https://irct.ir/trial/89795 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Laryngospasm. Intervention 1: Intervention group:. In the intervention group, LMA insertion will be performed using lidocaine gel (Xylogel 2%, Sinadaroo, Iran). Intervention 2: Control group: In the control group, LMA insertion will be performed using simple lubricant gel (Paliz Teb lubricating gel, Iran). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Alireza Mahdavi
Before Mirdamad Street, Dr. Ali Shariati Street
Tehran Iran (Islamic Republic of) ۱۵۵۱۴۱۵۴۶۸ +98 21 2222 7029 alirezamahdavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Alireza Mahdavi
Before reaching Mirdamad Street, Dr. Ali Shariati Street
Tehran Iran (Islamic Republic of) ۱۵۵۱۴۱۵۴۶۸ +98 21 2222 7029 alirezamahdavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) American Society of Anesthesiologists (ASA) Physical Status Classification System: Class 1 Candidates undergoing surgery with Laryngeal Mask Airway (LMA) insertion Parental consent for participation in the study Pediatric weight between 5 to 20 kg no limit 18 years Both The duration of the surgery more than 2 hours Bleeding that leads to blood transfusion during surgery Surgical complication leading to severe hemodynamic instability of the patient during surgery Airway problems such as obstruction J38.5 Laryngeal spasm Treatment - Other Treatment - Other Intervention group:. In the intervention group, LMA insertion will be performed using lidocaine gel (Xylogel 2%, Sinadaroo, Iran) Control group: In the control group, LMA insertion will be performed using simple lubricant gel (Paliz Teb lubricating gel, Iran). Laryngospasm. Timepoint: During extubation of the laryngeal airway mask. Method of measurement: standardized laryngospasm grading scale. Cough. Timepoint: After transferring the patient to recovery and 12 hours after the end of surgery. Method of measurement: Cough Severity Grading Scale. Shahid Beheshti University of Medical Sciences Approved 2025-10-08 Ethics Committee of School of Medicine, Shahid Beheshti University of Medical Sciences Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)