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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.

ConditionsPediatricElectiveSurgery in Early Childhood
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-12
SponsorAssiut University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Parental/guardian consent.

Age 2-12 years

ASA physical status I-II.

Elective surgery requiring LMA (duration <2 hours).

Disqualifiers

Known airway anomalies (e.g., tonsillar hypertrophy, cleft palate).

Cardiovascular disease (bradycardia, arrhythmias).

Allergy to study drugs.

BMI >95th percentile.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group (D) DEXActive comparator 1 intervention
Group B: Group (L) LidocaineActive comparator 1 intervention

Trial outcomes

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.

Time frame
After induction of anesthesia

Secondary outcomes

1

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.

Time frame
After Induction of anesthesia
2

Heart rate

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

Time frame
Every 15 minutes till recovery
3

MAP

Mean arterial blood pressure

Time frame
Every 15 minutes
4

Recovery Time

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

Time frame
After cessation of anesthesia administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: