The Impact of Using Muscle Relaxants and Laryngeal Local Anesthetics for Laryngeal Mask Airway (LMA) Insertion on Hemodynamics and Induction Anesthetics Dosage in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Propofol requirement
研究概览
简要总结
Laryngeal mask airway (LMA) is currently the most widely used supraglottic airway device with advantages of simple and fast placement, reduced anesthesia drug use, more stable hemodynamics, and less throat discomfort after anesthesia compared to endotracheal intubation. Some studies claimed the use of muscle relaxants or local anesthetics (sprays or lubricants containing local anesthetics) for the throat before LMA placement can reduce the dosage of induction agents and postoperative throat complications.
In modern society, more and more elderly people undergo elective surgery with the need of general anesthesia. However, they are the more vulnerable population with tendency of greater hemodynamic changes with more induction agent usage. Propofol is one of the most used induction agents which may lead to a drop in blood pressure. The objective of this study is to observe whether the dose of propofol and the changes in hemodynamics can be reduced by using muscle relaxants or laryngeal local anesthetics in elderly who receiving general anesthesia with LMA insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Age: over 65 years
- •Elective orthopedic surgery undergo general anesthesia in supine position
排除标准
- •Anticipated difficult airway (Mallampati score 3-4), limited mouth opening, intra-oral and pharyngeal pathology
- •Risk of pulmonary aspiration of gastric contents (full stomach)
- •Obesity (Body mass index > 35)
- •Significant lung abnormalities (low lung compliance, high airway resistance, impaired oxygenation)
- •Loosening teeth
- •Allergic to Cisatracurium or Lidocaine
- •Failure in successful LMA insertion after second attempts
研究组 & 干预措施
10% lidocaine spray and cisatracurium group
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
干预措施: 10% lidocaine spray (Drug)
10% lidocaine spray and cisatracurium group
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
干预措施: Cisatracurium (Drug)
10% lidocaine spray and cisatracurium group
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
干预措施: Propofol (Drug)
10% lidocaine spray and placebo of cisatracurium group
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1.25 mg/kg.
干预措施: 10% lidocaine spray (Drug)
10% lidocaine spray and placebo of cisatracurium group
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1.25 mg/kg.
干预措施: Placebo of cisatracurium (Drug)
10% lidocaine spray and placebo of cisatracurium group
The subjects received laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1.25 mg/kg.
干预措施: Propofol (Drug)
Placebo of lidocaine spray and cisatracurium group
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
干预措施: Placebo of lidocaine spray (Drug)
Placebo of lidocaine spray and cisatracurium group
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
干预措施: Cisatracurium (Drug)
Placebo of lidocaine spray and cisatracurium group
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous cisatracurium 0.12 mg/kg, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 1 mg/kg.
干预措施: Propofol (Drug)
Placebo group
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 2 mg/kg.
干预措施: Placebo of lidocaine spray (Drug)
Placebo group
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 2 mg/kg.
干预措施: Placebo of cisatracurium (Drug)
Placebo group
The subjects received normal saline spray as a substitute for laryngeal local anesthetics (10% lidocaine spray), intravenous normal saline as a substitute for cisatracurium, and propofol before laryngeal mask airway placement. The predetermined dosage of propofol for the first subject is 2 mg/kg.
干预措施: Propofol (Drug)
结局指标
主要结局
Propofol requirement
时间窗: one minute after propofol infusion
The minimal propofol requirement dose was defined as the median effective dose (ED50) of movement or increased mean arterial pressure (MAP) to no movement or stable MAP. The ED50 is the average of the crossover midpoints found during conducting the Dixon's up-and-down method.
次要结局
- Coughing or gagging(Within 1 minute after LMA placement)
- Oxygen saturation (SpO2)(0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement)
- Ease of LMA insertion(Procedure (At the same time of LMA placement))
- Non-invasive blood pressure (NIBP)(0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement)
- Heart rate (HR)(0 minute, 1 minute, 2 minute, 3 minute, 4 minute, 5 minute, 10 minute after LMA placement)
- Head or body movement(Within 1 minute after LMA placement)
- Peak pressure (P peak) of the airway(0 minute after LMA placement)
- Hiccups(Within 1 minute after LMA placement)
- Mean pressure (P mean) of the airway(0 minute after LMA placement)
- Ease of jaw opening(Procedure (At the same time of LMA placement))
- Attempts for LMA insertion(Procedure (At the same time of LMA placement))
- Complications(One hour after LMA removal)
- Laryngospasm(Within 1 minute after LMA placement)
研究者
Yu-Ting, Hung
Principal Investigator
Chang Gung Memorial Hospital