The Effect of Anaesthesia Depth on Oculo-cardiac Reflex in Strabismus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The effect of the anaesthesia depth on the incidence of oculocardiac reflex
研究概览
简要总结
This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery.
详细描述
The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients during strabismus surgery. It is presumed that the depth of anesthesia is one of the influencing factor on the OCR. But the clinical trials which are evaluating the relationship between the anesthesia depth and OCR are scarce. The main objective of this study is to determine the impact of the depth of anaesthesia that is adjusted with the bispectral index (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physical status ASA (American Society of Anesthesiologists) I
- •scheduled for elective strabismus surgery under general anesthesia
- •aged between 3-16 years
排除标准
- •have a neurological or cardiovascular disease
- •receiving antiepileptic or another medications known to affect EEG or ECG
研究组 & 干预措施
BIS<50
Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values below 50.
干预措施: Desflurane (Drug)
BIS<50
Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values below 50.
干预措施: Bispectral index monitoring (Device)
BIS≥50
Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values above 50.
干预措施: Desflurane (Drug)
BIS≥50
Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values above 50.
干预措施: Bispectral index monitoring (Device)
结局指标
主要结局
The effect of the anaesthesia depth on the incidence of oculocardiac reflex
时间窗: during the traction of the extra-ocular muscle in the strabismus surgery
次要结局
- The incidence of the oculocardiac reflex depending the type of operated extra-ocular muscle during the strabismus surgery(during the traction of the extra-ocular muscle in the strabismus surgery)
研究者
Tuğba Karaman
assistant professor
Tokat Gaziosmanpasa University