Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
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
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Siyament Cangir, M.D.
- 电话号码：+905534411047
- 邮箱：siyamentcangir@gmail.com
研究联系人备份
- 姓名：Fatma K Acil, M.D.
- 电话号码：+905337225225
- 邮箱：acilfatma@gmail.com
学习地点
-
-
Outside of the US
-
Diyarbakır、Outside of the US、土耳其（türkiye）、21070
- 招聘中
- Siyament Cangir
-
接触：
- Fatma Acil, M.D.
- 电话号码：+905337225225
- 邮箱：acilfatma@gmail.com
-
接触：
- Siyament Cangir, M.D.
- 电话号码：+905534411047
- 邮箱：siyamentcangir@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
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.
其他名称：
|
|
实验性的：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.
|
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients achieving adequate sedation at anesthesia induction
大体时间：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
|
Approximately 30 minutes after premedication, at anesthesia induction
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Parent-child separation anxiety score
大体时间：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 |
At parent-child separation before anesthesia induction
|
|
Mask acceptance at induction
大体时间：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.
|
At the time of mask application during anesthesia induction
|
|
Postoperative emergence agitation
大体时间：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.
|
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
|
Need for rescue sedation
大体时间：From premedication until anesthesia induction
|
Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
|
From premedication until anesthesia induction
|
|
PACU recovery time
大体时间：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.
|
During PACU stay until discharge criteria are met
|
|
Postoperative pain score
大体时间：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.
|
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
|
Extubation time
大体时间：Intraoperative to immediate postoperative period
|
Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
|
Intraoperative to immediate postoperative period
|
|
Mean Arterial Pressure (MAP)
大体时间：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 |
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)
大体时间：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) |
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).
|
|
Oxygen Saturation (SpO2)
大体时间：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 (%) |
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).
|
合作者和调查者
调查人员
- 研究主任：Fatma Acil, M.D.、Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 27/01/2026-35
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.