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临床试验/NCT05139212
NCT05139212已完成不适用

An Optimum Time for Intravenous Cannulation After General Anesthesia Induction With Sevoflurane and Nitrous Oxide in Children Undergoing Elective Surgery With Dexmedetomidine Premedication

Karaman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with dexmedetomidine

研究概览

简要总结

Inhalational induction with sevoflurane, nitrous oxide, and oxygen is accepted as a safe technique to avoid any movement during intravenous cannulation in children. In addition, intranasal dexmedetomidine could be used for premedication to reduce preoperative anxiety in preschool children. Early attempts to place, an intravenous line may result in movement and respiratory complications like coughing or laryngospasm. On the other hand delay in cannulation may prevent effective management of bradycardia and hypotension. There are a number of studies examining the optimum time for cannulation after sevoflurane induction. However, it is not known whether the addition of dexmedetomidine premedication affects the time for intravenous cannulation following induction with sevoflurane and nitrous oxide.

详细描述

All the children will be premedicated with intranasal 2mcg/kg dexmedetomidine 40 minutes before the surgery. Ramsay sedation scale and Turkish version of modified Yale Preoperative Anxiety Scale (mYPAS) will be measured at the time of arrival in the daycare unit and during anesthesia preparation in the operating room.

The same anesthesia machine will be used in all children with the same circuit volume. The circuit will be emptied and then filled with sevoflurane (8%) and nitrous-oxygen (50:50) for 30 seconds at a high fresh gas flow (6 liter/minute). The timer will be started when the face mask is placed on the child's face for inhalational induction.

The exhaled gas concentrations will be measured continuously. After the loss of eyelash reflex, the fresh gas flow will be reduced to 3 liter/minute, the sevoflurane will be reduced to 5% and the timer will be restarted. Spontaneous respiration will be allowed until intravenous cannulation and ventilation will be gently assisted as required.

For the first child, the gas flow settings will be maintained for 4 minutes from the loss of eyelash reflex before intravenous cannulation is attempted. All intravenous cannulation will be performed on the dorsum of the hand by an experienced anaesthesiologist, using a 24-gauge stainless steel guide cannula.

At the time of intravenous cannulation attempt, an independent observer, who will be blinded about the predetermined cannulation time, will rate the movement according to a scale (0= no movement, 1= slight extremity tension, 2= extremity withdrawal, 3= generalized movement).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with ASA physical status I and scheduled for an elective procedure under general anesthesia without prior intravenous cannulation will be selected

排除标准

  • Children posted for any emergency procedure
  • ASA class II and above,
  • Children with abnormal airway anatomy.
  • Children with active respiratory infection in the last 3 weeks.
  • Children who are being treated with sedative or anticonvulsive agents.
  • Children with heart, lung, neurologic, or central nervous system disorders.

结局指标

主要结局

Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with dexmedetomidine

时间窗: The outcome will be assessed at the time of intravenous cannulation attempt.

At the time of intravenous canulation attempt, an independent observer who will be blinded about predetermined canülation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement. Intravenous cannulation without any laryngospasm or movement will be considered successful.

次要结局

  • To assess level of preoperative sedation(Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.)
  • To assess level of preoperative anxiety(Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.)

研究者

发起方
Karaman Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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