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.

NCT07562308 | Not Yet Recruiting DMC

• 1 other identifier: DEX and LMA insertion success
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric; Elective; Surgery in Early Childhood

Keywords

Dexmedetomidine, Lidocaine, LMA, Pediatrics, Elective

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ease of insertion (4-point scale)

  After Induction of anesthesia

• Heart rate

  Every 15 minutes till recovery

• MAP

  Every 15 minutes

• Recovery Time

  After cessation of anesthesia administration

• Postoperative Agitation

  In PACU

Study Arms (2)

Group (D) DEX

ACTIVE COMPARATOR

Dose: 0.2 mcg/kg IV in 10 mL saline, infused over 10 min pre-induction.

Drug: Dexamedomedine

Group (L) Lidocaine

ACTIVE COMPARATOR

Dose: 1.5 mg/kg IV (max 100 mg) in 10 ml saline over 1 min before induction.

Drug: Lidocaine (drug)

Interventions

Dexamedomedine DRUG

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

Also known as: DEX, Precedex

Group (D) DEX

Lidocaine (drug) 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

Group (L) Lidocaine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, Asyut Governorate, 71621, Egypt

Location

Related Publications (3)

• 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.

  PMID: 30878762 BACKGROUND

• 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.

  PMID: 35016404 BACKGROUND

• 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.

  PMID: 26473098 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Lidocaine; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Abdelrahman Hamdy

  Asyut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelrahman Hamdy, Lecturer

CONTACT

+201060989574; abdelrahmanhm89@gmail.com

Mohammed Adel, Lecturer

CONTACT

01050727722

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia & ICU, Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2027 after publishing the study and for 1 year after

Locations

EG (1)