Pediatric, Elective, Surgery in Early Childhood
Conditions
Keywords
Dexmedetomidine, Lidocaine, LMA, Pediatrics, Elective
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.
Interventions
DRUGDexamedomedine
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
DRUGLidocaine (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
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt insertion success rate | After induction of anesthesia | The success of the first trial of classic LMA insertion will be assessed. Binary: yes or no. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of insertion (4-point scale) | 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. |
| Heart rate | Every 15 minutes till recovery | Monitored continuously and recorded every 15 minutes. Atropine IV will be given if bradycardia occurs. |
| MAP | Every 15 minutes | Mean arterial blood pressure |
| Recovery Time | After cessation of anesthesia administration | Time from discontinuation of anesthesia till the child is fully awake. |
| Postoperative Agitation | In PACU | PAED scale 1. The child makes eye contact with the caregiver 2. The child's actions are purposeful 3. The child is aware of his/her surroundings 4. The child is restless 5. The child is inconsolable |
| Postoperative Complications | 0,1,2,6 hours postoperative. | Laryngeal Spasm, Coughing |
| PONV | 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 |
| Postoperative sore throat (0-3 scale). | 24 hours postoperative | 0 (none) 1. (mild/complaint only upon asking) 2. (moderate/complaint on own) 3. (severe/hoarseness or throat pain). |
Countries
Egypt
Contacts
CONTACTAbdelrahman Hamdy, Lecturer
CONTACTMohammed Adel, Lecturer
PRINCIPAL_INVESTIGATORAbdelrahman Hamdy
Asyut University
Outcome results
None listed