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Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 10
Healthy Volunteers: f
View:

• 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

• Written informed consent obtained from parents or legal guardians

Locations
Other Locations
Turkey
Siyament Cangir
RECRUITING
Diyarbakır
Contact Information
Primary
Siyament Cangir, M.D.
siyamentcangir@gmail.com
+905534411047
Backup
Fatma K Acil, M.D.
acilfatma@gmail.com
+905337225225
Time Frame
Start Date: 2026-05-05
Estimated Completion Date: 2026-09-26
Participants
Target number of participants: 84
Treatments
Experimental: Dexmedetomidine Group
Participants in this group will receive intranasal dexmedetomidine at a dose of 2 mcg/kg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.
Active_comparator: Midazolam Group
Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) as premedication 30 minutes prior to anesthesia induction, along with intranasal placebo to maintain blinding. This approach ensures consistent administration routes across study groups.
Related Therapeutic Areas
Sponsors
Leads: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

This content was sourced from clinicaltrials.gov