Sevoflurane Versus Propofol for Laryngeal Mask Airway Placement in Children Undergoing Surgery
Comparison of Sevoflurane and Propofol for Laryngeal Mask Airway Insertion in Children
The goal of this clinical trial is to compare two commonly used anesthetic medicines, sevoflurane and propofol, for inserting a laryngeal mask airway (LMA) in children undergoing minor elective surgery. A laryngeal mask airway is a device placed in the throat to help children breathe safely during anesthesia.
The main questions this study aims to answer are:
- Does sevoflurane produce a faster onset of anesthesia than propofol?
- Is there a difference between sevoflurane and propofol in the time required to achieve jaw relaxation for LMA insertion?
- Is there a difference between the two medicines in the time required for successful LMA insertion?
The researchers hypothesize that children receiving sevoflurane will have a shorter induction time than those receiving propofol.
A total of 170 children aged 4 to 12 years who are undergoing minor surgical procedures below the umbilicus will participate in the study. Participants will be randomly assigned to receive either intravenous propofol or inhaled sevoflurane for induction of anesthesia.
During the procedure, the anesthesia team will measure the time taken to lose consciousness, the time required to achieve adequate jaw relaxation, and the time needed for successful insertion of the laryngeal mask airway. These measurements will help determine which anesthetic agent provides better conditions for LMA insertion in children.
研究概览
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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Punjab Province
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Multan、Punjab Province、巴基斯坦、60000
- Children's Hospital and Institute of Child Health Multan
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- ASA physical status 1 and 2
- Undergoing elective minor surgical procedures below umbilicus
- Procedure lasting less than 60 min
Exclusion Criteria:
- Recent respiratory tract infection
- Bronchial asthma
- Family history of malignant hyperthermia
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：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Propofol Group
Children in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion.
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Intravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients.
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实验性的：Sevoflurane Group
hildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion.
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Sevoflurane 7% will be delivered via inhalation in a nitrous oxide/oxygen mixture (2:1) for induction of general anesthesia prior to LMA insertion in pediatric patients.
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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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Time to Induction of Anesthesia
大体时间：From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
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Time (in seconds) measured from administration of the induction agent (propofol or sevoflurane) to loss of consciousness, defined as loss of verbal response and loss of eyelash reflex in pediatric patients undergoing elective surgery for laryngeal mask airway insertion.
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From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Jaw Relaxation
大体时间：From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
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Time (in seconds) measured from administration of induction agent to adequate jaw relaxation, defined as sufficient mouth opening (>4 cm) allowing insertion of laryngeal mask airway.
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From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
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Time to Laryngeal Mask Airway (LMA) Insertion
大体时间：From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
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Time (in seconds) measured from administration of induction agent to successful insertion of laryngeal mask airway using standard technique.
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From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
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合作者和调查者
调查人员
- 学习椅：Syed S Abbas, FCPS、Children's Hospital and Institute of Child Health, Multan
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
propofol的临床试验
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Kaohsiung Medical University Chung-Ho Memorial...Tri-Service General Hospital招聘中