Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sameh Fathy
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of eye movements
研究概览
简要总结
This study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post operative recovery. It is hypothesized that controlled ventilation without muscle relaxation will be advantageous to other modes in providing adequate surgical satisfaction with considerable depth of anesthesia and better recovery profile.
详细描述
Anesthetic management in pediatric cataract surgery constitutes a special challenge. Any eye movements can lead to an unsatisfactory surgical field and increase the risk of ophthalmological complications. Achieving adequate ventilation of children is considered another challenge due to huge variability in size and lung maturity. Spontaneous breathing is a popular mode of ventilation with several beneficial effects. Controlled ventilation without muscle relaxation using laryngeal mask airway is attractive option because the side effects of muscle relaxants are avoided. Therefore, this study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post-operative recovery. This prospective, randomized, comparative clinical study will include 150 children who will be scheduled for elective cataract surgery under general anesthesia in Mansoura ophthalmology center over one year. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to three equal groups according to computer-generated table of random numbers using the permuted block randomization method. In the first group, spontaneous ventilation will be maintained with pressure support; while in the two other groups, mechanical ventilation will be applied with pressure controlled modes. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) I and II patients.
- •Scheduled for elective cataract surgery.
排除标准
- •Parental refusal of consent.
- •Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
- •Hyperactive airway disease or respiratory diseases.
- •Children with developmental delays, mental or neurological disorders.
- •Bleeding or coagulation diathesis.
- •History of known sensitivity to the used anesthetics.
- •Previous surgery in the same eye.
研究组 & 干预措施
Spontaneous Ventilation
Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Pressure Support Ventilation (Procedure)
Spontaneous Ventilation
Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Laryngeal Mask Airway (Device)
Spontaneous Ventilation
Patients will spontaneously ventilated. Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Sevoflurane (Drug)
Unparalyzed Controlled Ventilation
Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Unparalyzed Pressure Control Ventilation (Procedure)
Unparalyzed Controlled Ventilation
Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Laryngeal Mask Airway (Device)
Unparalyzed Controlled Ventilation
Patients will be mechanically ventilated without muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Sevoflurane (Drug)
Paralyzed Controlled Ventilation
Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Paralyzed Pressure Control Ventilation (Procedure)
Paralyzed Controlled Ventilation
Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Laryngeal Mask Airway (Device)
Paralyzed Controlled Ventilation
Patients will be mechanically ventilated with muscle relaxation.Laryngeal mask airway will be inserted and anesthesia is maintained with sevoflurane.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Incidence of eye movements
时间窗: Up to the end of the surgery
Incidence any upward or downward deviation of the vision axis during surgery will be recorded
次要结局
- Changes in mean arterial blood pressure(Up to the end of the surgery)
- Improvement in postoperative emergence agitation scale(Up to 30 minutes after surgery)
- Amount of consumption of sevoflurane(Up to the end of the surgery)
- Changes in heart rate(Up to the end of the surgery)
- Changes in bispectral index(Up to the end of the surgery)
- Changes in dynamic compliance(Up to the end of the surgery)
- Value of surgeon satisfaction from the procedure(After the end of the surgery)
- Changes in intraocular pressure(Up to the end of the surgery)
研究者
Sameh Fathy
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
Mansoura University
