Intravenous Dexmedetomidine Vs. Lidocaine for Laryngeal Mask Insertion Conditions In Pediatric Patients Undergoing Elective Surgeries, A Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- First-attempt insertion success rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group (D) DEX
Dose: 0.2 mcg/kg IV in 10 mL saline, infused over 10 min pre-induction.
Intervention: Dexamedomedine (Drug)
Group (L) Lidocaine
Dose: 1.5 mg/kg IV (max 100 mg) in 10 ml saline over 1 min before induction.
Intervention: Lidocaine (drug) (Drug)
Outcomes
Primary Outcomes
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
- 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)
- Postoperative Complications(0,1,2,6 hours postoperative.)
- PONV(24 hours postoperative)
- Postoperative sore throat (0-3 scale).(24 hours postoperative)
Investigators
Abdelrahman Hamdy Mohammed
Lecturer of Anesthesia & ICU, Faculty of Medicine, Assiut University
Assiut University