Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sameh Fathy
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of oculocardiac reflex
研究概览
简要总结
This study is conducted to evaluate importance of bispectral index (BIS) monitoring in patients undergoing strabismus surgery when using propofol in comparison to sevoflurane anesthesia regarding their effects on oculocardiac reflex, intraoperative hemodynamic stability, emergence agitation, postoperative pain, nausea and vomiting.
详细描述
Strabismus surgery can cause unfavorable side effects during intraoperative and postoperative periods including increased risk of the oculocardiac reflex, hemodynamic instability, emergence agitation, postoperative pain, nausea and vomiting. Sevoflurane is an inhalation anesthetic widely used in pediatric anesthesia with minimal airway irritation. Propofol is an intravenous sedative-hypnotic agent with amnestic properties that causes loss of consciousness. Bispectral index monitor provide some more evidence that deeper anesthesia can provide some protection against the oculocardiac reflex. Therefore, this study is conducted to evaluate the role of BIS monitoring in comparing the use of propofol and sevoflurane anesthesia in pediatric strabismus surgery.
This prospective, randomized, comparative clinical study will include 100 children who are scheduled for elective strabismus surgery under general anesthesia in Mansoura ophthalmology center. Informed written consent is obtained from parents of all subjects in the study after ensuring confidentiality. The study protocol is explained to parents of all patients in the study who are kept fasting prior to surgery. Patients are randomly assigned to two equal groups according to computer-generated table of random numbers using the permuted block randomization method. The collected data are coded, processed, and analyzed using SPSS program. All data are 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
- 3 Years 至 8 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 Strabismus surgery.
排除标准
- •Parental refusal of consent.
- •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.
- •Children with previous surgery in the eye.
研究组 & 干预措施
Sevoflurane Group
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
干预措施: Bispectral Index Monitor (Device)
Sevoflurane Group
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
干预措施: Laryngeal Mask Airway (Device)
Sevoflurane Group
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
干预措施: Sevoflurane (Drug)
Propofol Group
Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
干预措施: Bispectral Index Monitor (Device)
Propofol Group
Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
干预措施: Laryngeal Mask Airway (Device)
Propofol Group
Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of oculocardiac reflex
时间窗: Up to the end of the surgery
Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.
次要结局
- First analgesic request(Up to 24 hours after surgery)
- Changes in bispectral index(Up to the end of the surgery)
- Changes in heart rate(Up to the end of the surgery)
- Changes in postoperative emergence agitation scale(Up to 30 minutes after surgery)
- Changes in mean arterial blood pressure(Up to the end of the surgery)
- Changes in postoperative pain score(Up to 24 hours after surgery)
- Incidence of postoperative nausea and vomiting(Up to 24 hours after surgery)
- Total analgesic requirements of paracetamol(Up to 24 hours after surgery)
研究者
Sameh Fathy
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
Mansoura University
