The Role of BIS-Guided Anesthesia in Reducing Emergence Delirium in Children (Çocuklarda Derlenme Deliryumunun Azaltılmasında BİS Kılavuzluğunda Anestezi)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure 1: Incidence of Emergence Delirium Assessed by the PAED Scale
研究概览
简要总结
The goal of this clinical trial was to learn if using a brain monitor to adjust anesthesia (sleep medicine) during surgery could prevent emergence delirium (severe confusion and agitation upon waking) in children aged 2 to 12 years having their tonsils or adenoids removed. The main questions it aimed to answer were:
Did using a brain monitor lower the chance of children waking up confused and upset?
Did using the brain monitor reduce the amount of anesthesia gas (sevoflurane) needed during surgery, and did it affect recovery time or pain levels?
Researchers compared anesthesia adjusted using a bispectral index (BIS) brain monitor to anesthesia adjusted using standard care to see if the brain monitor lowered the chance of emergence delirium.
Participants in the study:
Received general anesthesia (a standardized mix of inhaled and intravenous medicines, including sevoflurane and fentanyl) to safely sleep through surgery to remove their tonsils or adenoids
Had the dose of their main anesthesia gas (sevoflurane) adjusted during surgery based on either brain monitor readings (targeting a specific sleep depth of 40-60) or standard physical responses (like heart rate and blood pressure)
Were checked by the research team immediately after waking up to measure their confusion, agitation, and pain using standard clinical rating scales
详细描述
Emergence delirium (ED) represents a significant neurobehavioral complication that frequently occurs during the immediate postoperative period in pediatric populations, particularly following otorhinolaryngological procedures such as adenoidectomy and tonsillectomy. Characterized by severe agitation, altered awareness, disturbed psychomotor behavior, and inconsolability, ED poses safety risks to the recovering patient and increases the burden on healthcare providers and caregivers. While the etiology of ED is multifactorial, the intraoperative depth of anesthesia and the cumulative exposure to specific volatile anesthetics, such as sevoflurane, are known modifiable risk factors. Both excessively deep and inadequately light anesthesia can contribute to poor recovery profiles. The Bispectral Index (BIS) is an electroencephalogram (EEG)-based monitor that provides an objective measurement of a patient's level of consciousness, allowing anesthesiologists to precisely titrate anesthetic agents to an optimal depth.
This prospective, randomized controlled study was designed to investigate the role of BIS-guided anesthetic titration in mitigating the risk of ED. Upon enrollment, pediatric patients undergoing adenoidectomy and/or tonsillectomy were randomized into one of two clinical care pathways: a BIS-guided anesthesia group or a standard-care group.
To ensure baseline consistency across the study, all participants followed a standardized anesthetic induction protocol. Following routine premedication, general anesthesia was induced using inhaled sevoflurane combined with intravenous lidocaine, rocuronium (for muscle relaxation), and fentanyl (for analgesia). For the maintenance phase of anesthesia, patients in both arms received a combination of inhaled sevoflurane and continuous remifentanil infusions.
The critical divergence in the study protocol occurred during the intraoperative maintenance phase:
BIS-Guided Pathway: Anesthesiologists continuously monitored the patient's EEG activity using the BIS monitor. The concentration of the sevoflurane gas was deliberately titrated to maintain a BIS value between 40 and 60, which represents an optimal and safe depth for surgical anesthesia. By keeping patients within this precise target range, the protocol systematically avoided periods of excessively deep (BIS < 40) or overly light (BIS > 60) anesthesia.
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)
盲法说明
This was a single-blind clinical trial. Participants and their guardians were masked to the study arm assignment. Anesthesia care providers could not be masked to the intervention assignment itself, as they were required to actively titrate the anesthesia based on the assigned method. However, a specific masking protocol was used for the active comparator group to prevent bias. In the standard care group, the BIS monitor was applied to the patient to record data, but the screen was completely covered. This ensured the care provider remained masked to the actual BIS values during the surgery, forcing them to rely solely on standard hemodynamic-guided titration.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 2 and 12 years
- •Scheduled for a planned surgery to remove adenoids, tonsils, or both
- •Generally healthy or having only mild medical conditions (American Society of Anesthesiologists class I or II)
- •Expected to have a surgery that lasts less than 4 hours
- •Having the procedure as an outpatient and expected to go home the same day
排除标准
- •Having severe medical conditions (American Society of Anesthesiologists class III or IV)
- •Having a known history of neurological or psychiatric diseases
- •Diagnosed with a developmental delay
- •Having severe heart, lung, or metabolic conditions
- •Having a known allergy to any of the medications used in the study
- •Parents or legal guardians refuse to provide written consent to participate
研究组 & 干预措施
BIS-Guided Anesthesia
This group received the specific intervention (the BIS monitor to guide anesthesia depth) that is the main focus of your research study.
干预措施: BIS-Guided Anesthesia (Device)
Standard Care Anesthesia
This group received the standard, established method of care (titrating anesthesia based on heart rate and blood pressure).
干预措施: Standard Care Anesthesia (Drug)
结局指标
主要结局
Primary Outcome Measure 1: Incidence of Emergence Delirium Assessed by the PAED Scale
时间窗: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale ranges from a minimum of 0 to a maximum of 20. Higher scores mean a worse outcome (more severe delirium). Scores of 10 or higher were classified as a positive diagnosis for emergence delirium.
Primary Outcome Measure 2: Incidence of Emergence Delirium Assessed by the Watcha Scale
时间窗: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Evaluated postoperatively using the Watcha behavioral scale. The scale ranges from a minimum of 1 to a maximum of 4. Higher scores mean a worse outcome (greater agitation and delirium). Scores of 3 to 4 were classified as a positive diagnosis for emergence delirium.
Primary Outcome Measure 3: Incidence of Emergence Delirium Assessed by the Cravero Scale
时间窗: Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.
Evaluated postoperatively using the Cravero behavioral scale. The scale ranges from a minimum of 1 to a maximum of 5. Higher scores mean a worse outcome (greater agitation). Scores of 4 or higher were classified as a positive diagnosis for emergence delirium.
次要结局
- Total Sevoflurane Consumption(Intraoperative (From anesthesia induction until the completion of surgery).)
- Postoperative Pain Assessed by the FLACC Scale(Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation.)
- Rescue Opioid Usage(Up to 60 minutes during the post-anesthesia recovery period.)
- Recovery Time(Up to 4 hours (From transfer to the recovery unit until discharge criteria were successfully met).)