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.

This prospective, randomized, double-blind, controlled clinical trial aims to compare intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.

Premedication is essential in pediatric anesthesia to reduce preoperative anxiety, facilitate parent-child separation, and improve cooperation during anesthesia induction. Oral midazolam is widely used but has limitations such as variable bioavailability and potential adverse behavioral effects. Dexmedetomidine, a selective α2-adrenoreceptor agonist, has emerged as an alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.

Eligible pediatric patients will be prospectively enrolled and randomly assigned to receive either intranasal dexmedetomidine or oral midazolam. A double-blind design will be maintained by administering both oral and intranasal preparations in each group. Premedication will be administered prior to anesthesia induction, and perioperative clinical parameters will be recorded.

This study is expected to provide clinically relevant evidence regarding the effectiveness and safety of intranasal dexmedetomidine compared to oral midazolam, potentially contributing to improved premedication strategies in pediatric anesthesia.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Chronic use of analgesics or other medications that may affect study outcomes
• Anticipated difficult airway
• Nasal pathology that may interfere with intranasal drug administration
• Emergency surgery
• Inability to obtain written informed consent from parents or legal guardians

De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.

Starting 6 months and ending 36 months following article publication.

Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to acilfatma@gmail.com

This is a double-blind study in which both participants and outcome assessors are blinded to treatment allocation. Study drugs are prepared by an independent investigator. To ensure blinding, both oral and intranasal administrations are given to all participants, with one active drug and one placebo in each group.