Hydroxyzine Dihydrochloride Premedication is a Necessity for Pediatric Patients Undergoing Strabismus Surgery; An Observational Clinical Trial Controlled With Midazolam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Heart Rate-1
研究概览
简要总结
Oculocardiac reflex (OCR) is usually happening in pediatric strabismus surgery and observed just when the surgent pulls the ocular muscles. The reflex is one of the trigemino-vagal reflexes, and causes bradycardia, arrhythmia, and even cardiac arrest during eye surgery.
Premedication for relaxation with drugs like hydroxyzine dihydrochloride or midazolam before surgery of the pediatric population is often used in Turkey, although it is not recommended in foreign countries. Some recent studies showed that when midazolam and hydroxyzine dihydrochloride used together not only, they lessen agitation before surgery but also they prevent emergence agitation.
The primary aim of this prospective observational study is to show the effect of hydroxyzine dihydrochloride on preventing the pediatric patient from Oculocardiac reflex related to strabismus surgery.
详细描述
Strabismus surgery is a frequently performed surgery in the Turkish population from one year of age to adults. Oculocardiac reflex(OCR) is the most recent complication happens during the operation, and it occurs approximately 20% to 80% according to its definition, in strabismus surgery.
OCR is defined as the presence of dysrhythmia or a sudden heart rate decreased by 20% after traction on the extraocular muscles. OCR is one of the trigemino-vagal reflexes and causes bradycardia, arrhythmia and even cardiac arrest during eye surgery. To prevent patients from this complication the operator and anesthesiologist must cooperate during the operation because the first treatment is to stop traction of the muscle, the second one is to use atropine after diagnosing bradycardia.
Oculocardiac reflex related trials were done for decades; searching for how and when it happens, which ocular muscles are related mostly, or which patients are at risk of OCR( age, heart rate related) are the most researched ones. According to our knowledge, there is no research about a premedication to prevent OCR during strabismus surgery.
Before this study has planned by the investigator, the investigator had seen many OCR occurrence related to strabismus surgery, treated either with pausing the surgery or with atropin intravenous utilization in other clinics. After started working in this university hospital the investigator recognized those pediatric patients whom premedicated do not need to treat in the strabismus surgery because the OCR incidence was decreased dramatically. The investigator has planned this observational research at Yeditepe University Hospital because in this hospital pediatric patients receive variable oral premedication for sedation before surgery and for the prevention of emerging agitation. In Yeditepe University Hospital oral premedication( with variable drugs and variable doses) is nearly always ordered by anesthesiologists unless there is a comorbidity or allergy anamnesis related to the drugs planning to use.
This current study is planned as observational. The investigator does not allow to give any orders about premedications or treatments before or during strabismus surgery. The Induction and the maintenance of anesthesia are also variable because there is no intervening to the anesthetist who performs anesthesia. The anesthetist who orders the premedication and performs anesthesia during strabismus surgery is not related to the trial and do not know the aim of the trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Strabismus, surgery needed
- •Esotropia, surgery needed
排除标准
- •Chronic disease
- •Arrhythmia
- •Glaucoma(narrow-angle)
研究组 & 干预措施
Midazolam
Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.
In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.
干预措施: Midazolam (Drug)
Midazolam&Hydroxyzine dihydrochloride1/2
Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.
In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.
干预措施: Midazolam (Drug)
Midazolam&Hydroxyzine dihydrochloride1/2
Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.
In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.
干预措施: Hydroxyzine Dihydrochloride (Drug)
Midazolam&Hydroxyzine dihydrochloride
Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.
In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.
干预措施: Midazolam (Drug)
Midazolam&Hydroxyzine dihydrochloride
Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists.
In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively.
干预措施: Hydroxyzine Dihydrochloride (Drug)
结局指标
主要结局
Heart Rate-1
时间窗: 1 minute, at the "time out", through study completion an average of 6 months
The lowest heart rate observed from EKG monitorization at the "time-out" after the anesthesia induction, and just before the surgery starts. Heart rate-1 is a data, not an assessing change, which is recoded during the "time-out". "The time-out" is when the patient's name, the procedure, the surgent name is repeated before the operation starts.
Heart Rate-2
时间窗: 1 minute, at the strabismus surgery operation, through study completion an average of 6 months
The heart rate observed from EKG monitorization at the time operator warns the investigator just before the traction of the orbital muscle. Heart rate-2 is a data, not an assessing change, which is recorded during the operation at the time operator warns. The heart rate observed from EKG monitorization, before every orbital muscle traction at the time the operator's warning before traction.
Heart Rate-3
时间窗: within 120 seconds after the orbital muscle traction, at the strabismus surgery operation, through study completion an average of 6 months
The lowest heart rate observed from EKG monitorization, after every orbital muscle traction within 120 seconds. Heart rate-3 is a data, not an assessing change, which is recorded within 120 seconds after traction applied.
Number of Observed Oculocardiac Reflex(OCR)
时间窗: 2 minutes, at the strabismus surgery operation after recording Heart Rate-3, through study completion an average of 6 months
The OCR is a heartbeat anomaly(bradycardia, any arrhythmia, or cardiac arrest) associated with traction applied to the extraocular muscles during strabismus surgery. The specific criteria were as follows: the lowest heart rate observed within 120 seconds from EKG monitorization, after every orbital muscle traction, was less than 20% of the heart rate observed directly preceding traction of the orbital muscle. Additionally, any kind of arrhythmia or cardiac arrest occurrence within 120 seconds after orbital muscle traction was also defined as an OCR.
次要结局
- Ramsay Sedation Score(After patient transferred into the operation theatre and before anesthesia induction, through study completion an average of 6 months)
研究者
Fatma Ferda Kartufan
Assistant Professor
Yeditepe University