Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-10
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dexmedetomidine
  • Midazolam

Treatment groups

84 Participants
are divided into 2 treatment groups