The Effects of Remifentanil and Remifentanil-Alfentanil Administration on Emergence Agitation After Brief Ophthalmic Surgery in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- the incidence of emergence agitation
研究概览
简要总结
Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating airway properties, rapid induction and emergence. However, it is associated with emergence agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a cause of stress to both caregivers and families. Various pharmacologic agents have been suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This study was designed to compare the effects of remifentanil and remifentanil combining alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.
详细描述
One hundred and two children, aged 3-9 years, undergoing ophthalmic surgery were studied. General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane. At the time of separation from parents, separation score was recorded. When the children have a separation score of three or four point, they received half dose of thiopental before going to the operation room. They randomly assigned to group S (sevoflurane alone) or group R (sevoflurane with remifentanil infusion at the rate of 0.1 ㎍/kg/min) or group A (sevoflurane with remifentanil infusion and intravenous injection of alfentanil 5 ㎍/kg 10 min before the end of surgery). Mean arterial pressure (MAP), heart rate (HR) and sevoflurane concentration were checked every 15 minutes after induction of anesthesia. Time to extubation from discontinuation of sevoflurane inhalation was measured. Time to discharge from postanesthesia care unit (PACU) was assessed with postanesthetic Aldrete recovery score. Emergence agitation scoring system was used to evaluate the incidence and severity of EA.
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
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children who were scheduled to undergo ophthalmic surgery under general anesthesia
排除标准
- •developmental delay, neurologic or psychologic disease,
- •history of sleep apnea,
- •or history of general anesthesia
研究组 & 干预措施
Sevoflurane
Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated.
干预措施: Sevoflurane (Other)
Sevoflurane
Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated.
干预措施: Thiopental (Drug)
Sevoflurane
Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated.
干预措施: Rocuronium (Drug)
Remifentanil
Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Sevoflurane (Other)
Remifentanil
Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Remifentanil (Drug)
Remifentanil
Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Thiopental (Drug)
Remifentanil
Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Rocuronium (Drug)
Alfentanil
Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery.
The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Sevoflurane (Other)
Alfentanil
Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery.
The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Remifentanil (Drug)
Alfentanil
Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery.
The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Alfentanil (Drug)
Alfentanil
Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery.
The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Thiopental (Drug)
Alfentanil
Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery.
The incidence and severity of emergence agitation was compared with sevoflurane group.
干预措施: Rocuronium (Drug)
Thiopental
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Sevoflurane (Other)
Thiopental
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Remifentanil (Drug)
Thiopental
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Alfentanil (Drug)
Thiopental
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Thiopental (Drug)
Thiopental
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Rocuronium (Drug)
Rocuronium
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Sevoflurane (Other)
Rocuronium
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Remifentanil (Drug)
Rocuronium
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Alfentanil (Drug)
Rocuronium
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Thiopental (Drug)
Rocuronium
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
干预措施: Rocuronium (Drug)
结局指标
主要结局
the incidence of emergence agitation
时间窗: during recovery time in PACU (within 1 hour)
次要结局
未报告次要终点