Emergence Agitation, Pediatric Anesthesia, Preoperative Anxiety
Conditions
Keywords
Pediatric Anesthesia, Preoperative Anxiety, Emergence Agitation
Brief 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.
Detailed description
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.
Interventions
DRUGDexmedetomidine
Intranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
DRUGMidazolam
Oral midazolam administered at a dose of 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups to receive either intranasal dexmedetomidine or oral midazolam as premedication. Both groups will receive both intranasal and oral administrations to maintain blinding, with one active drug and one placebo in each group.
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving adequate sedation at anesthesia induction | Approximately 30 minutes after premedication, at anesthesia induction | Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent-child separation anxiety score | At parent-child separation before anesthesia induction | Parent-child separation anxiety will be assessed using the Parental Separation Anxiety Scale (PSAS). The scale ranges from 1 to 4, where 1 indicates "calm/easy separation" and 4 indicates "crying/extreme difficulty in separation." Higher scores represent worse outcomes (higher levels of anxiety). A score of \>2 is defined as significant separation anxiety. Unit of Measure: Units on a scale |
| Mask acceptance at induction | At the time of mask application during anesthesia induction | Mask acceptance will be assessed using the Mask Acceptance Scale (MAS ) at the time of mask application during anesthesia induction. Mask Acceptance will be defined as WDS 1-2. |
| Postoperative emergence agitation | At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9 | Emergence agitation will be assessed using the Watcha Behavior Scale (WDS). Agitation will be defined as WDS \>2. |
| Need for rescue sedation | From premedication until anesthesia induction | Requirement for rescue sedation during the preoperative period will be recorded as yes/no. |
| PACU recovery time | During PACU stay until discharge criteria are met | Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9. |
| Postoperative pain score | At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9 | Postoperative pain will be assessed using the FLACC scale. |
| Extubation time | Intraoperative to immediate postoperative period | Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube. |
| Mean Arterial Pressure (MAP) | At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min). | Mean arterial pressure (MAP) will be monitored to evaluate hemodynamic stability during the perioperative period. Unit of Measure: mmHg |
| Heart Rate (HR) | At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min). | Heart rate (HR) will be recorded to monitor cardiac stability and response to anesthesia. Unit of Measure: Beats per minute (bpm) |
| Oxygen Saturation (SpO2) | At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min). | SpO2 levels will be monitored via pulse oximetry to evaluate respiratory and hemodynamic status. Unit of Measure: Percentage (%) |
Countries
Turkey (Türkiye)
Contacts
CONTACTSiyament Cangir, M.D.
CONTACTFatma K Acil, M.D.
STUDY_DIRECTORFatma Acil, M.D.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Outcome results
None listed