Preoperative Dexmedetomidine & EC50 of Propofol (PreopDXM)
Preoperative Dexmedetomidine Reduces the EC50 of Propofol for Successful i-gelTM Insertion Without Muscle Relaxants
研究概览
地位
条件
详细说明
Propofol is a useful induction agent for LMA insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. A previous report showed that the effect-site concentration of propofol for successful classic LMA insertion in 50% of adults (EC50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. The EC50 of propofol may be dependent on the type of LMA used. A previous study comparing the EC50 of the propofol concentration between classic and proseal LMA insertions demonstrated that the EC50 of propofol needed for proseal LMA insertion was 35% greater than that needed for classic LMA insertion. Unfortunately, no investigation has been performed to determine the EC50 of the propofol concentration required for i-gel insertion without muscle relaxants.
Dexmedetomidine (DEX), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. Such beneficial characteristics make DEX a useful anaesthetic adjuvant for general anaesthesia. Many reports have revealed the beneficial effects of DEX in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. A previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the EC50 required for LMA insertion.
We hypothesised that preoperative DEX administration can reduce the propofol concentration required for i-gel insertion. In this study, we compared the EC50 of propofol needed for successful i-gel insertion without muscle relaxants between DEX and placebo groups
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Seoul、大韩民国、110-799
- Seoul National University of Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery
Exclusion Criteria:
- Patients with an allergy to alpha-2 adrenergic agonists or propofol
- Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of <2.5 cm, and/or body mass index of >30 kg m-2), unstable teeth
- Patients with bradycardia of <50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
- Patients with symptoms of upper respiratory infection
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group D : Dexmedetomidine + propofol group
In Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia.
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All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment. |
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安慰剂比较：Group C : Saline + propofol group
In Group C, 0.9% of normal saline (1 µg kg-1) was loaded 10 min before induction of anaeshtesia.
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All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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EC50 of propofol required for successful i-gel insertion
大体时间：During i-gel insertion anticipated up to 1 min
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The EC50 of propofol for successful i-gel insertion was determined by a modification of Dixon's up-and-down method.
The response of each patient determined the effect-site propofol concentration for the next patient.
If the response was deemed 'successful', the next target concentration of propofol was decreased by 0.5 µg mL-1.
If the response was deemed a 'failure', the target concentration was increased by the same dose.
The process was repeated until the sixth crossover point (success/failure) was obtained.
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During i-gel insertion anticipated up to 1 min
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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the total dose of propofol infused before i-gel insertion
大体时间：During i-gel insertion time anticipated upto 1min
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The total amount of propofol infused before i-gel insertion was noted.
The insertion time, defined as the time from picking up the i-gel until the initiation of mechanical ventilation.
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During i-gel insertion time anticipated upto 1min
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the presence/severity of airway trauma after i-gel insertion
大体时间：At the time point of removing the i-gel from patient's mouth
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After removing the i-gel, airway trauma (defined as any blood staining on the device) was recorded.
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At the time point of removing the i-gel from patient's mouth
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合作者和调查者
调查人员
- 研究主任：Hee Pyung Park, MD PhD、Professor
- 首席研究员：Young Cheol Kim, Md PhD、Professor
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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