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NCT Number: NCT07562308

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.

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.

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Key information

Conditions

Pediatric Elective Surgery in Early Childhood

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Assiut University

Asyut, Asyut Governorate, 71621, Egypt

Location contact

Abdelrahman Hamdy

CONTACT

[email protected]

01060989574

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: DEX, Precedex

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

Primary outcomes

  1. First-attempt insertion success rate

    Time frame: After induction of anesthesia

    The success of the first trial of classic LMA insertion will be assessed. Binary: yes or no.

Secondary outcomes

  1. Ease of insertion (4-point scale)

    Time frame: After Induction of anesthesia

    Grade 1: No resistance. Grade 2: Mild resistance. Grade 3: Moderate resistance. Grade 4: Failed insertion and need for another airway management tool.

  2. Heart rate

    Time frame: Every 15 minutes till recovery

    Monitored continuously and recorded every 15 minutes. Atropine IV will be given if bradycardia occurs.

  3. MAP

    Time frame: Every 15 minutes

    Mean arterial blood pressure

  4. Recovery Time

    Time frame: After cessation of anesthesia administration

    Time from discontinuation of anesthesia till the child is fully awake.

  5. Postoperative Agitation

    Time frame: In PACU

    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

  6. Postoperative Complications

    Time frame: 0,1,2,6 hours postoperative.

    Laryngeal Spasm, Coughing

  7. PONV

    Time frame: 24 hours postoperative

    PONV grade Patient response 0 Without PONV I Nausea without vomiting II Nausea with vomiting (< 3 times/d) III Vomiting ≥ 3 times/d

  8. Postoperative sore throat (0-3 scale).

    Time frame: 24 hours postoperative

    0 (none)

    • (mild/complaint only upon asking)
    • (moderate/complaint on own)
    • (severe/hoarseness or throat pain).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Hamdy, Lecturer

CONTACT

[email protected]

+201060989574

Mohammed Adel, Lecturer

CONTACT

01050727722 ext. +2

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: DEX LMA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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