Comparison of Sevoflurane and Propofol for Laryngeal Mask Airway Insertion in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Time to Induction of Anesthesia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1 and 2
- •Undergoing elective minor surgical procedures below umbilicus
- •Procedure lasting less than 60 min
排除标准
- •Recent respiratory tract infection
- •Bronchial asthma
- •Family history of malignant hyperthermia
研究组 & 干预措施
Sevoflurane Group
hildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion.
干预措施: Sevoflurane (Drug)
Propofol Group
Children in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion.
干预措施: propofol (Drug)
结局指标
主要结局
Time to Induction of Anesthesia
时间窗: From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
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.
次要结局
未报告次要终点
研究者
Palwasha Sardar
Principal Investigator
Children's Hospital and Institute of Child Health, Multan