Comparison of Esketamine Versus Sevoflurane Add to Dexmedetomidine-based Sedation for Minor Ophthalmology Procedure in Children: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- the incidence of desaturation
研究概览
简要总结
Emergence agitation is the most common reason for post-anesthesia care unit delay. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been successfully used for keeping spontaneous breathing without tracheal intubation. However, sevoflurane may cause emergence agitation as the incidence varied from 10%-80%. Although there are many sedative agents to reduce its incidence, such as propofol, midazolam, a2 adrenergic receptor agonists and ketamine, the efficacy remains limited.
Ketamine, a neuroleptic anesthetic agent, contains two optical isomers, s(+)-ketamine (esketamine) and R(-)-ketamine. Esketamine is a right-handed split of ketamine, which has enhanced analgesic potency and lower incidence of psychotropic side effects compared to ketamine. It stimulate breathing due to N-Methyl-D-Aspartate receptor blockade, and could even effectively countered remifentanil-induced respiratory depression. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless ophthalmological procedure in pediatric patients.
详细描述
Ophthalmological procedure such as suture remove, intraocular pressure (IOP) measurement, slit-lamp and fundoscopy are most frequently performed in operation with minor surgical stimulus, and the the duration of surgery is very short. Several anesthestic agents are available,but it is hard to balance short effect and fast rotation in post-anesthesia care unit. Emergence agitation is the most common reason for post-anesthesia care unit delay. Sevoflurane is used frequently inhalational anaesthetic agent to provide pediatric anaesthesia because of the nonirritant nature. It has been successfully used for keeping spontaneous breathing without tracheal intubation. However, sevoflurane may cause emergence agitation as the incidence varied from 10%-80%. Although there are many sedative agents to reduce its incidence, such as propofol, midazolam, a2 adrenergic receptor agonists and ketamine, the efficacy remains limited.
Ketamine, a neuroleptic anesthetic agent, contains two optical isomers, s(+)-ketamine (esketamine) and R(-)-ketamine. Esketamine is a right-handed split of ketamine, which has enhanced analgesic potency and lower incidence of psychotropic side effects compared to ketamine. It stimulate breathing due to N-Methyl-D-Aspartate receptor blockade, and could even effectively countered remifentanil-induced respiratory depression. Additionally, several studies have reported ketamine could reduced agitation, but there is no study about esketamine on emergence agitation. The investigators compared the effectiveness of esketamine and sevoflurane in reducing the incidence of emergence agitation after painless 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists physical status 1-2
- •required to remove the stitches by microscope after corneal surgeries
排除标准
- •psychiatric disorders
- •cardiovascular disorders
- •contraindications to nasal intubation
研究组 & 干预措施
Group E
1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 0.25mg·kg-1 esketamine was administered by vein in one minute, and 0.25mg·kg-1 esketamine was given at the beginning of the surgery.
干预措施: Esketamine (Drug)
Group S
1ug· kg-1 dexmedetomidine and 0.01mg·kg-1 atropine was administered intravenously. 4% sevoflurane(FIO2=100%, 3L·min-1) was used to induce anesthesia by mask inhalation and 2-4 % sevoflurane (adjusted according to the depth of the anaesthesia,FIO2=100%, 2L·min-1) was maintained.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
the incidence of desaturation
时间窗: duration from the time patient received induction to the time of leaving to the ward, average 1 hour
the incidence of oxygen saturation below 95% caused by anesthetic agent.
the incidence of hypotension
时间窗: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of systolic blood pressure\< 30% of basal systolic blood pressure and lasted \>5 minutes.
the incidence of respiratory depression
时间窗: duration from the time patient received induction to the time of leaving to the ward, average 1 hour
respiratory rate \<12 times per min or weak chest undulation
the incidence of hypertension
时间窗: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of systolic blood pressure \> 30% of basal systolic blood pressure
the incidence of emergence agitation
时间窗: duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 20 minutes
the incidence of emergence agitation
the incidence of tachycardia
时间窗: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of heart rate increase over 30% of pre-induction and\>120 beats per minute.
the incidence of bradycardia
时间窗: duration from the time patient received induction to the end of the anesthesia, average 15 minutes.
the incidence of heart rate less than 60 beats per minute
次要结局
- diastolic pressure(1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation)
- intraocular pressure(the time after intubation and topical anesthesia within 1 minute)
- 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 minutes)
- CPS score(scores at the time point of 1 minutes after extubation)
- systolic pressure(1minutes before induction; 1minutes before intubation; 1minutes after intubation; 3 minutes after intubation)
- heart rate(1minutes before induction; 1minutes before intubation;1minutes after intubation,3 minutes after intubation)
- extubation time(duration from the time that patients arrived in post-anesthesia care unit to the time of extubation, average 10 minutes)