Actively Recruiting
Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
Led by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Updated on 2026-05-14
84
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 2 to 10 years
- ASA physical status I-II
- Scheduled for elective inguinal or urological surgery under general anesthesia
- Both male and female patients
- Written informed consent obtained from parents or legal guardians
You will not qualify if you...
- Known allergy or hypersensitivity to dexmedetomidine or midazolam
- Significant systemic disease or organ dysfunction
- Cardiac arrhythmia or congenital heart disease
- Neurological or behavioral disorders, including developmental delay
- Chronic use of analgesics or medications affecting study outcomes
- Anticipated difficult airway
- Nasal pathology interfering with intranasal drug administration
- Emergency surgery
- Inability to obtain written informed consent from parents or legal guardians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Siyament Cangir
Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
Actively Recruiting
Research Team
S
Siyament Cangir, M.D.
CONTACT
F
Fatma K Acil, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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