Changes in Perfusion Index Under Low-Flow Anesthesia and Its Effects on Postoperative Emergence in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Perfusion Index (PI)
研究概览
简要总结
This study aims to evaluate changes in perfusion index (PI) in pediatric patients undergoing elective surgery under low-flow anesthesia. PI will be monitored at multiple intraoperative and postoperative time points to assess its relationship with hemodynamic stability and depth of anesthesia. The study will also investigate whether low-flow anesthesia affects the incidence of emergence agitation (EA). Patients will be assigned to either low-flow or normal-flow anesthesia groups based on routine clinical practice. No intervention will be applied beyond standard care. The findings are expected to provide insight into the predictive value of PI in postoperative recovery and support safer anesthesia practices in pediatric populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Group allocation is determined by the anesthesia provider during routine care. Both the participant and the outcome assessor are blinded to group assignment. Data analysis is performed without group identifiers.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II pediatric patients
- •Age 2 to 12 years
- •Undergoing elective surgery lasting between 1-6 hours
- •Informed consent obtained from parents/guardians
排除标准
- •Cardiovascular, respiratory, neurological, metabolic, or endocrine disorders
- •Premature birth with corrected age < 2 years
- •Obesity or severe malnutrition (BMI <5th or >95th percentile)
- •Psychiatric or neurodevelopmental disorders (e.g., autism)
- •Malignant hyperthermia or hypersensitivity to anesthetics
- •Emergency surgeries
- •Lack of IV access requiring inhalational induction
- •Contraindications to low-flow anesthesia including:
- •Severe pulmonary disease
- •Congenital heart disease with shunt physiology
- •Anticipated high oxygen demand
- •Airway obstruction risk
- •Surgeries requiring high gas flow or >6 hours duration
研究组 & 干预措施
Low-Flow Anesthesia Group (LFA)
Patients will receive general anesthesia using a fresh gas flow rate of 1 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at predetermined time points.
干预措施: Low-Flow Anesthesia (LFA) (Procedure)
Normal-Flow Anesthesia Group (HFA)
Patients will receive general anesthesia using a fresh gas flow rate of 2 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at the same time points.
干预措施: Low-Flow Anesthesia (LFA) (Procedure)
结局指标
主要结局
Change in Perfusion Index (PI)
时间窗: From induction to 30 minutes after extubation
Perfusion Index (PI) will be measured at 11 predefined perioperative time points to assess its intraoperative variation and its potential correlation with anesthesia depth and emergence profile in pediatric patients undergoing low-flow vs normal-flow anesthesia.
次要结局
未报告次要终点
研究者
İlke Dolgun
Assoc. prof
Istinye University