Comparison of Sedation by Esketamine and Sevoflurane for Short Ophthalmological Procedure in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- eye position scale
研究概览
简要总结
Pediatric diseases，including congenital cataract,，corneal injury，corneal ulcer, usually need suture removal and ophthalmic examination after Surgery for several days. Unfortunately, it remains a great challenge to achieve successful sedation due to children's noncooperation. Sevoflurane is one of the most often used anesthesia agents to provide deep sedation. Although sevoflurane has been used for pediatric anesthesia with successful keep spontaneous breathing without intubation, it should be noted that sevoflurane often results in air pollution under the open airway background and postoperative agitation.
Esketamine is the S (+) isomer of ketamine, which produces a dissociated state with minimal risk of airway compromise or apnea. It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause delirium during the recovery time. Based on these experiences on ketamine, we compared the effectiveness of esketamine and sevoflurane for short ophthalmological procedure in pediatric patients.
详细描述
Pediatric diseases，including congenital cataract,，corneal injury，corneal ulcer, usually need suture removal and ophthalmic examination after Surgery for several days. Unfortunately, it remains a great challenge to achieve successful sedation to avoid body movement and keep perfect eye position due to children's noncooperation. Thus, appropriate sedative agents therefore need to be administrated to perform this minor surgery. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been used for successful keeping spontaneous breathing without tracheal intubation. It should be noted that sevoflurane often results in air pollution under the open airway background and emergence agitation. High concentrations of sevoflurane may causes respiratory depression due to the decrease in tidal volume during spontaneous ventilation.
Ketamine is widely used for procedural sedation, which produces a dissociated state with minimal risk of airway compromise or apnea. Esketamine is the S (+) isomer of ketamine, It has enhanced analgesic potency and faster elimination compared to ketamine. However, it may also cause agitation during the recovery time. Based on these experiences on ketamine, we compared the effectiveness of esketamine and sevoflurane for short ophthalmological procedure in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who needed suture removal and ophthalmic examination
排除标准
- •previous coronary heart disease,hypertension, arterial aneurysm, epilepsia, intracranial mass of benign or malign nature
研究组 & 干预措施
group S
patients were anesthetized by face mask with 5 vol% sevoflurane with total 5 L/min-1 fresh gas flow. Anaesthesia was maintained by continuously using 3-4% sevoflurane.
干预措施: Sevoflurane (Drug)
group E
patients received 0.5mg/kg IV esketamine at first, after surgical field disinfection, another 0.25mg/kg IV esketamine was administered. Then 1mg/kg propofol was administered every 5 minutes after intubation.
干预措施: Esketamine (Drug)
结局指标
主要结局
eye position scale
时间窗: during the surgery
1=The inner and outer canthus line across the central cornea; 2= Inferior limbus does not exceed the inner and outer canthus line; 3= Inferior limbus exceed the inner and outer canthus line.
次要结局
- the incidence of respiratory depression(during the surgery)
- Intraocular pressure(the time after intubation and topical anesthesia within 1 minute)
- the incidence of desaturation(during the surgery)
- requirements for additional propofol(during the surgery)
- CPS score(scores at the time point of 1 minutes after extubation)
- Heart rate(1minutes before induction;1minutes after induction;1minutes before extubation;1minutes after extubation,3 minutes after extubation)
- length of stay in the post-anesthesia care unit(duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 mins)
- extubation time(duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 mins)
- Mean blood pressure pressure(1minutes before induction;1minutes after induction;1minutes before intubation;1minutes after intubation,3 minutes after intubation)