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临床试验/NCT02618525
NCT02618525已完成不适用

Comparison of the Supraorbital Pressure and Jaw Thrust as Indicators for Depth of Anesthesia for Laryngeal Mask Airway Insertion in Children

B.P. Koirala Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Number of successful LMA insertion at first attempt

研究概览

简要总结

BACKGROUND AND OBJECTIVES

The purpose of this study is to assess whether the loss of motor response to supraorbital pressure can be an alternative to that of jaw thrust to predict optimal condition for laryngeal mask airway (LMA) insertion in children.

METHODOLOGY

Fifty children (ASA I-II), aged 2 to 10 years, scheduled to receive general anesthesia that required LMA insertion were randomized to receive either supraorbital pressure (SOP) (n = 25) or jaw thrust (JT) (n = 25), after the loss of verbal response and body movements with a standard anesthetic. When motor response to the study intervention was absent, the LMA was inserted.

详细描述

The investigators enrolled fifty consecutive participants (aged one to ten years) with ASA physical status I or II scheduled to receive general anesthesia for various surgical procedures. Participants were allowed to have solid food, formula milk or cow's milk up to six hours, mother's milk up to four hours and clear fluid up to two hours before surgery.

On reaching the pre-operative room, when the participant was still on mothers lap or on the bed baseline measurements of non-invasive blood pressure (NIBP), pulse oximeter (SpO2) and electrocardiography (ECG) were taken. Fifteen minutes before induction of anesthesia, all participants were premedicated with ketamine, either 4mg/kg intramuscularly into the gluteal region with 26 G needle, or with 0.5mg/kg intravenously if intravenous (IV) cannula was in place.

Devices for ECG, SpO2 and NIBP monitoring were attached to the participant after arrival in the operating room. IV line was then inserted, if not already present. Pre-oxygenation was done with 100% oxygen using an appropriate size face mask. Anesthesia was induced with IV fentanyl (2mcg/kg), and propofol (2-4 mg/kg) until the loss of response to verbal contact or loss of eyelash reflex. Spontaneous ventilation was first assisted and then controlled manually to maintain an end-tidal carbon dioxide partial pressure of 33-40 mmHg. No neuromuscular blocking agent was administered.

Supraorbital pressure or jaw thrust was performed after loss of response to verbal contact, or absence of body movements. In group SOP, supraorbital pressure was applied over the supraorbital notch for five seconds. In group JT, the jaw thrust was applied gently by lifting the angles of the mandible vertically upward for five seconds. An IV bolus dose of propofol (1 mg/kg) was added if there was a motor response to the supraorbital pressure or the jaw thrust and the test was repeated after ten seconds. A second bolus dose of propofol was repeated if positive motor response was still present. A negative physical response to the test was considered as the end point of induction to perform LMA insertion. A classic LMA of appropriate size was inserted immediately. Ease of insertion and mouth opening, development of coughing, swallowing, movement, laryngospasm, or gross purposeful movements during or within one minute of LMA insertion and additional dosage of propofol if required were recorded. The LMA insertion was considered unsuccessful if LMA could not be inserted after administration of second bolus dose of propofol. The number of attempts and the insertion conditions were recorded using a six variable three points scoring system(31)

  • Mouth opening: 1 - Full, 2 - Partial (not ideal but permits easy opening of mouth), 3 - Nil
  • Ease of LMA insertion 1 - Easy, 2 - Difficult, 3 - Impossible.
  • Swallowing: 1 - Nil, 2 - Mild, 3 - Severe
  • Coughing: 1 - Nil, 2 - Mild, 3 - Severe
  • Laryngospasm: 1 - Nil, 2 - Mild (relieved by positive pressure ventilation), 3 - Severe (desaturation<90%)
  • Movement: 1 - Nil, 2 - Mild (Finger) (some movement but did not affect positioning of LMA), 3 - Severe (Arm/leg) (holding of LMA was required and additional dose of induction agent given).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status 1 and 2

排除标准

  • Congenital, acute or chronic heart and lung disease, Skull fracture or orbital fracture

研究组 & 干预措施

Supraorbital pressure

Active Comparator

Supraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow.

干预措施: Jaw thrust maneuver (Other)

Jaw thrust maneuver

Active Comparator

Jaw thrust maneuver is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth.

干预措施: Supraorbital pressure (Other)

结局指标

主要结局

Number of successful LMA insertion at first attempt

时间窗: Upto 1 minute after LMA insertion

次要结局

  • Ease of insertion of LMA(Upto 1 minute after LMA insertion)
  • Adequacy of mouth opening(Upto 1 minute after LMA insertion)
  • LMA insertion score(Upto 1 minute after LMA insertion)
  • Non invasive blood pressure(Upto 5 minute after LMA insertion)
  • Incidence of swallowing(Upto 1 minute after LMA insertion)
  • Incidence of coughing(Upto 1 minute after LMA insertion)
  • Incidence of laryngospasm(Upto 1 minute after LMA insertion)
  • Incidence of movement(Upto 1 minute after LMA insertion)
  • Additional bolus dose of propofol if required(Upto 1 minute after LMA insertion)
  • Heart rate(Upto 5 minute after LMA insertion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Asish Subedi

Principal Investigator

B.P. Koirala Institute of Health Sciences

研究点 (1)

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