Comparison Between the Effects of Adding Intranasal Dexmedetomidine to Two Different Doses of Midazolam as a Premedication in Pediatrics Undergoing Elective Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Mask Acceptance Score (MAS) at time of induction
研究概览
简要总结
The goal of this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are:
Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects?
How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events?
Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects.
Participants will:
Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam.
Undergo sedation scoring at 15 and 30 minutes after drug administration.
Be assessed for ease of separation from parents and acceptance of anesthesia mask.
Be monitored for vital signs, recovery times, and any perioperative adverse events.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 1 to 8 years
- •Scheduled for elective surgery under general anesthesia
- •Surgery duration < 1 hour
- •ASA physical status I or II
- •Parent or legal guardian able to provide informed consent
排除标准
- •Refusal to participate by parent/guardian
- •Nasal infections, pathology, or epistaxis
- •Runny nose or upper respiratory tract infection
- •Hepatic Dysfunction or significant liver disease
- •BMI > 30
- •Known allergy to dexmedetomidine or midazolam
- •Fever on day of surgery
- •Coagulopathy
- •Scheduled for cardiothoracic or neurosurgical procedures
- •Congenital heart disease
- •Neurological or mental disorders
- •Pre-existing sedation (MOASS < 5) on the day of surgery
研究组 & 干预措施
Dexmedetomidine + Midazolam 0.4 mg/kg
干预措施: Dexmedetomidine + Midazolam 0.4 mg/kg (Drug)
Dexmedetomidine + Midazolam 0.2 mg/kg
干预措施: Dexmedetomidine + Midazolam 0.2 mg/kg (Drug)
结局指标
主要结局
Mask Acceptance Score (MAS) at time of induction
时间窗: At the time of induction (approximately 30 minutes after premedication)
Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups.
次要结局
- Sedation Level (MOASS) at 15 and 30 minutes after premedication(15 minutes and 30 minutes after drug administration)
- Blood Pressure(Baseline and immediately before anesthesia induction)
- Heart Rate(Baseline and immediately before anesthesia induction.)
- Child-Parent Separation Score(Approximately 30 minutes after premedication (at time of separation))
- Time to Recovery (Modified Aldrete Score ≥ 9)(From extubation until Modified Aldrete Score ≥9 is achieved, assessed up to 1 hour in the Post-Anesthesia Care Unit (PACU))
- Perioperative Adverse Events(From the time of drug administration until 1 hour post-discharge from the Post-Anesthesia Care Unit (PACU), or until the occurrence of a recorded adverse event, whichever comes first.)
- Heart Rate(Baseline, 30minutes after medication and at the time of anesthesia induction.)
- Blood Pressure(Baseline, 30minutes after medication and at the time of anesthesia induction.)
- Time to Recovery (Modified Aldrete Score ≥ 9)(From cessation of inhalational anaesthesia until Modified Aldrete Score ≥9 is achieved.)
- Time to Extubation(The time between the cessation of inhalational anesthesia and the removal of the endotracheal tube.)
- Perioperative Adverse Events(From the time of drug administration until discharge from the Post-Anesthesia Care Unit (PACU) to the Ward)
研究者
Ahmed AbdElaty Hamed Ellhwany
Assistant Lecturer
Misr University for Science and Technology