Effectiveness and Safety of 6% Versus 8% Sevoflurane for Anesthesia Induction in Pediatric Ophthalmic Minor Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PAED score
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness and safety of 6% versus 8% sevoflurane inhalation induction in pediatric patients undergoing minor ophthalmic surgery. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes include hemodynamic parameters, induction time, recovery time, and 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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 6 years (12-72 months)
- •Scheduled to undergo minor ophthalmic surgery (e.g., chalazion excision) under general anesthesia
- •American Society of Anesthesiologists (ASA) physical status I
- •Assessed as suitable for inhalation anesthesia by anesthesiologists
- •Written informed consent obtained from parents or legal guardians
排除标准
- •ASA physical status II or higher
- •Known hepatic or renal dysfunction
- •Congenital heart disease
- •History of malignant hyperthermia
- •Known allergy to sevoflurane
- •History of asthma or severe respiratory disease
- •Upper respiratory tract infection within the past 4 weeks
- •Anticipated difficult airway
- •Refusal of participation by parents or legal guardians
研究组 & 干预措施
Sevoflurane 8% Group
Participants received 8% sevoflurane inhalation for anesthesia induction via face mask.
干预措施: Sevoflurane (Drug)
Sevoflurane 6% Group
Participants received 6% sevoflurane inhalation for anesthesia induction via face mask.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
PAED score
时间窗: Within 30 minutes after recovery
Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale ranges from 0 to 20, with higher scores indicating more severe emergence delirium (worse outcome).
次要结局
- Cough(Perioperatively)
- Induction time(Immediately after anesthesia induction)
- Recovery time(Immediately after anesthesia discontinuation)
- Minimum alveolar concentration (MAC)(Perioperatively)
- Respiratory depression(Perioperatively)
- Hypoxia(Perioperatively)
- Nausea and vomiting(Immediately after anesthesia until discharge)
研究者
Laiwen Lv
Principal Investigator
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong