This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.
Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.
In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2.
Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.
Pediatric patients aged 2-10 years
ASA physical status I-II
Scheduled for elective inguinal or urological surgery under general anesthesia
Both male and female patients
Known allergy or hypersensitivity to dexmedetomidine or midazolam
Presence of significant systemic disease or organ dysfunction
Cardiac arrhythmia or congenital heart disease
Neurological or behavioral disorders, including developmental delay
Parallel
Dexmedetomidine
DrugIntranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
Midazolam
DrugOral midazolam administered at a dose of 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
Proportion of patients achieving adequate sedation at anesthesia induction
Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction
Parent-child separation anxiety score
Parent-child separation anxiety will be assessed using the Parental Separation Anxiety Scale (PSAS). The scale ranges from 1 to 4, where 1 indicates "calm/easy separation" and 4 indicates "crying/extreme difficulty in separation." Higher scores represent worse outcomes (higher levels of anxiety). A score of \>2 is defined as significant separation anxiety. Unit of Measure: Units on a scale
Mask acceptance at induction
Mask acceptance will be assessed using the Mask Acceptance Scale (MAS ) at the time of mask application during anesthesia induction. Mask Acceptance will be defined as WDS 1-2.
Postoperative emergence agitation
Emergence agitation will be assessed using the Watcha Behavior Scale (WDS). Agitation will be defined as WDS \>2.
Need for rescue sedation
Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
Click on the lead sponsor to view all of their trials.
