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临床试验/NCT04241653
NCT04241653已完成不适用

Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery

Sameh Fathy1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月20日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

发起方
Sameh Fathy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sameh Fathy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

研究点 (1)

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