NCT02971254已完成2 期
The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
Asklepieion Voulas General Hospital1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in Cognitive Functions
研究概览
简要总结
Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification I, II or III
- •Down syndrome patients
- •must be able to undergone general anaesthesia
- •dental surgery necessity
排除标准
- •severe dementia
- •severe hearing, vision, speaking problems
研究组 & 干预措施
Sevoflurane group
Active Comparator
inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery
干预措施: Sevoflurane (Drug)
Desflurane group
Active Comparator
inhalation anaesthetic Desflurane, 1 M.A.C. during surgery
干预措施: Desflurane (Drug)
结局指标
主要结局
Change in Cognitive Functions
时间窗: Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery
Quantitative result measured by Prudhoe Cognitive Function Test (PCFT), a scale to assess cognitive function in adults with Down's syndrome.
次要结局
- Extubation(Interval between discontinuation of inhaled agent and extubation and up to 1 hour.)
- Antiemetics necessity.(Interval between entrance in PACU and administer antiemetic medication and up to 4 hours.)
- Patient Alertness, Wellness, Energy(4 hours after surgery)
- Postanesthesia Discharge Scoring System (PADSS)(Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.)
- Orientation in PACU(60 minutes after PACU entrance)
- Patient satisfaction over anaesthesia.(4 hours after surgery)
- Spontaneous breathing(Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.)
- Respond to commands(Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.)
- modified Aldrete Scoring System (mASS)(Interval between entrance in Post Operative Care Unit (PACU) and fulfillment of the criteria mASS to discharge PACU and up to 2 hours.)
- Painkillers necessity.(Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours.)
- Eye opening(Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.)
- Orientation(Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.)
研究者
Gkliatis Emmanouil
Anaesthetist
Asklepieion Voulas General Hospital
研究点 (1)
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