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Not yet recruiting 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.

No phase Interventional Pediatric Elective Surgery in Early Childhood

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamedomedine, Lidocaine (drug).
Who it may be relevant to
Registry conditions: Pediatric, Elective, Surgery in Early Childhood. Basic parameters: 2 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • First-attempt insertion success rate [Time frame: After induction of anesthesia]
Secondary outcome measures (8)
  • Ease of insertion (4-point scale) [Time frame: After Induction of anesthesia]
  • Heart rate [Time frame: Every 15 minutes till recovery]
  • MAP [Time frame: Every 15 minutes]
  • Recovery Time [Time frame: After cessation of anesthesia administration]
  • Postoperative Agitation [Time frame: In PACU]
  • Postoperative Complications [Time frame: 0,1,2,6 hours postoperative.]
  • PONV [Time frame: 24 hours postoperative]
  • Postoperative sore throat (0-3 scale). [Time frame: 24 hours postoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine Assiut University — Asyut

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. PMID 30878762
  • 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
  • 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

Identifiers

NCT: NCT07562308 · DEX and LMA insertion success

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗