Effects of Preoperative Using of Eye Patches on Prevention of Preschool Children Emergence Agitation After Cataract Surgery: A Single Center, Prospective, Randomized, Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- the Padiatric Anesthesia Emergence Agitation Scale
研究概览
简要总结
This study is a single-center, prospective, randomized, controlled trial. To investigate if preoperative using of eye patch will decrease emergence agitation, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.
详细描述
This study is a single-center, prospective, randomized, controlled trial. To investigate whether preoperative using of eye patches will decrease emergence agitation or not, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists. The investigators will recruit 180 children undergoing elective cataract surgery, divided into 2 groups by random method. experimental group will cover the effected eye for 3 hours before the operation, while the control group will not. Then the investigators will observe and mesure the incidence of emergence aditation in each group, to assess whether preoperative patch shading can reduce the incidence of postoperative agitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preschool patients undergo elective cataract surgery, whose age are 3 to 7 years.
- •Patients' parents agree to participate in the trial, and sigh the informed consent.
排除标准
- •Patient who can not communicate with medical workers preoperatively.
- •Both of patient's eyes are covered postoperatively.
- •Patient's parents refuse to sign informed consent.
- •The investigators do not think such patient is suitable for our research
- •The patient has serious arrhythmia, abnormal cardiac defect.
- •The patient has suffered from pneumonia, asthma symptoms, bronchitis, or upper respiratory tract infection recent two weeks.
- •The patient has serious disease of the nervous system.
- •The patient has the allergic history of any drug involved in this clinical trial.
结局指标
主要结局
the Padiatric Anesthesia Emergence Agitation Scale
时间窗: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
measure patients with the pediatric anesthesia emergence agitation scale,the score more than 10 is defined as emergence agitation.
次要结局
- induction compliance checklist(1 minute before general anesthesia began.)
- heart rate (HR)(every ten minutes postoperatively, up to 1 hour. Start measuring since every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.)
- respiration rate(RR)(every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.)
- oxygen saturation(SpO2)(every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.)
- incidence rate of emergence agitation(every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.)
研究者
Xiaoliang Gan
associate chief physician
Sun Yat-sen University