Actively Recruiting

Phase Not Applicable
Age: 2Years - 10Years
All Genders
NCT07565116

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

Age: 2Years - 10Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Siyament Cangir

Diyarbakır, Outside of the US, Turkey (Türkiye), 21070

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here