The Effect of Anesthesia Depth Monitoring on Emergence Agitation and Delirium in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- ED/EA incidence
研究概览
简要总结
Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.
Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.
In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of >12 points for the diagnosis of ED is 100% and the specificity is 94.5%.
Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.
There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed.
详细描述
During the compilation period after general anesthesia, cognitive status changes called emergence agitation and emergence delirium, clinically characterized by hallucinations, struggling, restlessness, crying, and disorientation, are observed. ED and EA often occur in the early postoperative period (especially in the first 30 minutes).
Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED/EA in the pediatric population. In our study, we aimed to determine the effect of sevoflurane anesthesia on the incidence of ED/EA under anesthesia depth monitoring.
Patients who give informed consent will be divided into 2 groups and randomized using the opaque sealed envelope method.
Children participating in the study will be evaluated with mYPAS, an anxiety assessment scale, in the preoperative period. Studies have found that children with high levels of anxiety have a higher frequency of developing maladaptive behavioral changes, pain, and ED after surgery.
On the day of surgery, patients will be taken to the operating room after premedication with 0.5 mg/kg po midazolam. Following routine noninvasive blood pressure, saturation and ECG monitoring; PEEG monitoring will be carried out with the help of pediatric sensors. Anesthesia guided by PEEG (processed electroencephalography) contributes to optimal targeting of the depth of anesthesia. The rationale for PEEG is to provide a simplified method for monitoring the depth of anesthesia through rapid interpretation of the frontal electroencephalogram (EEG). Thus, 4-channel raw EEG (L1, R1, L2 and R2 - equivalent to Fp1, F7, Fp2 and F8 according to the standard EEG monitoring system), electrode impedance, patient condition index (PSI), left and right spectral edge frequency (SEF95) and burst suppression ratio (SR) can be achieved. PSI; It is a dimensionless depth of anesthesia index that combines "weighted quantitative EEG parameters reflecting multiple dimensions of brain electrical activity." The correct depth of anesthesia is determined by the PSI value between 25 and 50.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 to 8 years old
- •Surgery time > 1 hour
- •Urology, Plastic Surgery and Pediatric Surgery patients
排除标准
- •Patients with neuromotor development abnormalities
- •Patients with a history of epilepsy/antiepileptic treatment
- •Patients receiving intraoperative ketamine administration
- •Patients requiring postoperative ICU admission
- •Surgeries performed under emergency conditions
- •Patients without parental consent
结局指标
主要结局
ED/EA incidence
时间窗: postoperative 5th, 15th and 30th minutes
The Pediatric Anesthesia Recovery Delirium (PAED) Scale Score will be used. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child must make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the surroundings, the child is restless/irritable, and the child cannot be consoled. A score of ≥10 will be considered EA, and a score of \>12 will be considered ED.
次要结局
- PSI >50 episode duration(intraoperative)
- mYPAS(immediately before induction of anesthesia)
- PSI <25 episode duration(intraoperative)
- PSI <25 number of episodes(intraoperative)
- SEF95R(intraoperatively every 15 minutes)
- SEF95L(intraoperatively every 15 minutes)
- Mean blood pressure(intraoperatively every 15 minutes)
- Total amount of sevoflurane used(at the end of surgery)
- Anesthesia duration(perioperative)
- Suppresyon ratio(intraoperatively every 15 minutes)
- PSI >50 number of episodes(intraoperative)
- Heart rate(intraoperatively every 15 minutes)
- SpO2(intraoperatively every 15 minutes)
- Total amount of remifentanil used(at the end of surgery)
- MAC(intraoperatively every 15 minutes)
- Waking up time(at the end of surgery)
- Pupil size(intraoperatively every 15 minutes)
- Surgery duration(perioperative)
- PHBQ(postoperative 3rd, 14th and 28th day)
- Ped-PADS(postoperative 30th, 45th and 60th minutes)
- Time of discharge from hospital(14 days after operation)
研究者
Meltem Savran Karadeniz
Associate Professor
Istanbul University