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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving adequate sedation at anesthesia induction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Midazolam (Drug)
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.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Proportion of patients achieving adequate sedation at anesthesia induction
时间窗: 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
次要结局
- Parent-child separation anxiety score(At parent-child separation before anesthesia induction)
- Mask acceptance at induction(At the time of mask application during anesthesia induction)
- Postoperative emergence agitation(At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9)
- Need for rescue sedation(From premedication until anesthesia induction)
- PACU recovery time(During PACU stay until discharge criteria are met)
- Postoperative pain score(At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9)
- Extubation time(Intraoperative to immediate postoperative period)
- 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).)
- 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).)
- 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).)
研究者
Siyament cangir
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital