Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. IV Dexmedetomidine Improves LMA Insertion Success and Decreases Coughing, While IV Lidocaine Decreases Postoperative Cough. (DEX LMA)

Intravenous Dexmedetomidine Vs. Lidocaine for Laryngeal Mask Insertion Conditions In Pediatric Patients Undergoing Elective Surgeries, A Randomized Controlled Trial.

Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. LMA may help in reducing postoperative pulmonary complications. IV Dexmedetomidine Improves LMA Insertion Success and Decreases trials number, While IV Lidocaine Decreases Postoperative Cough. This is a randomized interventional trial comparing both drugs. IV DEX will be compared vs IV lidocaine regarding the feasibility of insertion, number of trials, incidence of cough, postoperative pulmonary complications and hemodynamic profile.

Study Overview

• Status: Not yet recruiting
• Conditions: Elective; Pediatric; Surgery in Early Childhood
• Intervention / Treatment: Drug: Dexamedomedine; Drug: Lidocaine (drug)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelrahman Hamdy, Lecturer; Phone Number: +201060989574; Email: abdelrahmanhm89@gmail.com
• Study Contact Backup: Name: Mohammed Adel, Lecturer; Phone Number: +2 01050727722

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71621
      • Faculty of Medicine Assiut University
      • Contact: Abdelrahman Hamdy; Phone Number: 01060989574; Email: abdelrahmanhm89@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parental/guardian consent.
• Age 2-12 years
• ASA physical status I-II.
• Elective surgery requiring LMA (duration <2 hours).

Exclusion Criteria:

• Known airway anomalies (e.g., tonsillar hypertrophy, cleft palate).
• Cardiovascular disease (bradycardia, arrhythmias).
• Allergy to study drugs.
• BMI >95th percentile.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (D) DEX; Dose: 0.2 mcg/kg IV in 10 mL saline, infused over 10 min pre-induction.	Drug: Dexamedomedine; IV 0.2 mic/ kg of dexmedetomidine will be diluted over 10 ml saline and given to the patient over 10 minutes before induction and assess the feasibility of classic LMA insertion; Other Names: DEX, Precedex
Active Comparator: Group (L) Lidocaine; Dose: 1.5 mg/kg IV (max 100 mg) in 10 ml saline over 1 min before induction.	Drug: Lidocaine (drug); IV 1.5 mg/kg of lidocaine will be diluted over 10 ml saline and given to the patient 1 minute before induction and assess the feasibility of classic LMA insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt insertion success rate	The success of the first trial of classic LMA insertion will be assessed. Binary: yes or no.	After induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of insertion (4-point scale)	Grade 1: No resistance. Grade 2: Mild resistance. Grade 3: Moderate resistance. Grade 4: Failed insertion and need for another airway management tool.	After Induction of anesthesia
Heart rate	Monitored continuously and recorded every 15 minutes. Atropine IV will be given if bradycardia occurs.	Every 15 minutes till recovery
MAP	Mean arterial blood pressure	Every 15 minutes
Recovery Time	Time from discontinuation of anesthesia till the child is fully awake.	After cessation of anesthesia administration
Postoperative Agitation	PAED scale; The child makes eye contact with the caregiver; The child's actions are purposeful; The child is aware of his/her surroundings; The child is restless; The child is inconsolable	In PACU
Postoperative Complications	Laryngeal Spasm, Coughing	0,1,2,6 hours postoperative.
PONV	PONV grade Patient response 0 Without PONV I Nausea without vomiting II Nausea with vomiting (< 3 times/d) III Vomiting ≥ 3 times/d	24 hours postoperative
Postoperative sore throat (0-3 scale).	0 (none); (mild/complaint only upon asking); (moderate/complaint on own); (severe/hoarseness or throat pain).	24 hours postoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Abdelrahman Hamdy, Asyut University

Publications and helpful links

General Publications

• Li L, Zhang Z, Yao Z, Wang H, Wang H, An H, Yao J. The impact of laryngeal mask versus other airways on perioperative respiratory adverse events in children: A systematic review and meta-analysis of randomized controlled trials. Int J Surg. 2019 Apr;64:40-48. doi: 10.1016/j.ijsu.2019.02.020. Epub 2019 Mar 13.
• Ju Q, Xiao Z, Sun W, Zhu M, Lv P. The anesthesia induction effect of dexmedetomidine in patients undergoing laryngeal mask intubation: a systematic review and meta-analysis of 7 RCTs. Ann Palliat Med. 2021 Dec;10(12):12358-12366. doi: 10.21037/apm-21-2971.
• Gharaei B, Jafari A, Poor Zamany M, Kamranmanesh M, Aghamohammadi H, Roodneshin F, Teymourian H, Khazaie Y, Dadkhah P. Topical Versus Intravenous Lidocaine in Children With Upper Respiratory Infection Undergoing Anesthesia: A Randomized, Double Blind, Clinical Trial. Anesth Pain Med. 2015 Aug 22;5(4):e23501. doi: 10.5812/aapm.23501v2. eCollection 2015 Aug.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dexmedetomidine, Lidocaine, LMA, Pediatrics, Elective
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine; Dexmedetomidine; Pharmaceutical Preparations
• Other Study ID Numbers: DEX and LMA insertion success

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2027 after publishing the study and for 1 year after
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No