Optimization of Midazolam Administration Timing in Pediatric Adenotonsillectomy: Effects on Cortisol Response, Behavioral Stress, and Recovery Quality
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, randomized, controlled clinical trial designed to evaluate the optimal timing of midazolam administration in children undergoing adenotonsillectomy. The study will be conducted at the Departments of Otorhinolaryngology and Anesthesiology of Erzurum City Hospital.
Midazolam is commonly used in pediatric patients to reduce anxiety and improve perioperative comfort. However, the optimal timing of its administration (before surgery or during anesthesia induction) remains unclear. This study aims to compare the effects of preoperative oral midazolam and intraoperative intravenous midazolam on stress response, behavioral outcomes, and recovery quality.
Participants will be randomly assigned to one of two groups. In Group A, children will receive oral midazolam (0.5 mg/kg) 30 minutes before surgery. In Group B, children will receive intravenous midazolam (0.05-0.1 mg/kg) during anesthesia induction.
The primary outcome of the study is the change in serum cortisol levels, which reflects the physiological stress response. Blood samples will be collected twice: once 10 minutes after anesthesia induction and once 15 minutes after surgery in the post-anesthesia care unit.
In addition to cortisol levels, the study will assess preoperative anxiety using an observational anxiety scale, postoperative pain using a behavioral pain scoring system, and parental satisfaction using a standardized questionnaire. These measures aim to provide a comprehensive evaluation of the child's perioperative experience.
The findings of this study may help determine the most effective timing of midazolam administration to reduce stress, improve recovery, and enhance overall patient and family satisfaction in pediatric surgical care.
详细描述
This study is a prospective, randomized, controlled clinical trial designed to evaluate the effects of the timing of midazolam administration on physiological stress response, behavioral anxiety, postoperative pain, recovery quality, and parental satisfaction in pediatric patients undergoing elective adenotonsillectomy.
The primary objective is to compare the effect of midazolam administration timing on physiological stress response, assessed by serum cortisol levels. Secondary objectives include evaluating preoperative anxiety levels, postoperative pain scores, recovery quality, and parental satisfaction between groups receiving midazolam at different time points.
The study will include children aged 3-10 years, classified as ASA physical status I-II, scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy.
Eligible patients will be identified during preoperative anesthesia evaluation. Parents or legal guardians will be informed about the study, and written informed consent will be obtained prior to enrollment.
Participants will be randomly assigned to one of two groups using a computer-generated randomization sequence with sealed envelope allocation:
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
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3-10 years,
- •Scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy,
- •American Society of Anesthesiologists (ASA) physical status I-II,
- •Written informed consent obtained from parents or legal guardians
排除标准
- •Children younger than 3 years or older than 10 years,
- •American Society of Anesthesiologists (ASA) physical status greater than II,
- •Known allergy to apple or apple-derived products,
- •Known allergy or hypersensitivity to benzodiazepines,
- •Presence of developmental delay,
- •History of neuropsychiatric disorders,
- •Current or recent use of corticosteroids,
- •Expected or actual surgical duration longer than 90 minutes,
- •Refusal of participation by parents or legal guardians
研究组 & 干预措施
Intraoperative Intravenous Midazolam
Participants in this group will receive intravenous midazolam at a dose of 0.05-0.1 mg/kg during anesthesia induction.
干预措施: Midazolam (Intravenous) (Drug)
Preoperative Oral Midazolam
Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg, administered 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration and improve tolerance.
干预措施: Midazolam (Oral) (Drug)
研究者
Mehmet Sercan Orbak
Anesthesiology Specialist (MD), Principal Investigator
Erzurum City Hospital