Comparison of Patient Outcomes Between Anesthesia Administered Via Target-controlled Infusion Method and Inhalation Anesthesia Method in Pediatric Patients Undergoing Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Aldrete Scoring System
研究概览
简要总结
This study compares the effects of anesthesia using target-controlled infusion (TCI) and inhalation methods on pediatric patients undergoing inguinal hernia repair. The main outcomes include intraoperative hemodynamic stability and postoperative recovery characteristics. Sixty children were randomized to receive either total intravenous anesthesia (TIVA) via the Eleveld model or inhalation anesthesia with sevoflurane. The study aims to evaluate which method is safer and more effective in pediatric surgical anesthesia.
详细描述
This prospective, randomized, controlled study was conducted to evaluate the effects of two anesthesia techniques-target-controlled infusion using total intravenous anesthesia and inhalation anesthesia-on intraoperative hemodynamic stability and postoperative recovery quality in pediatric patients undergoing elective inguinal hernia repair. A total of 60 patients aged 3 to 12 years were randomly assigned to either the TIVA group, which received propofol via TCI using the Eleveld pharmacokinetic model, or the inhalation group, which received sevoflurane-based anesthesia. Standard monitoring included bispectral index (BIS), oxygen saturation (SpO₂), heart rate, and blood pressure measurements. Recovery was assessed using modified Aldrete scoring. A consistent anesthesia depth (BIS 40-60) and standardized ventilatory strategies were maintained for all participants. The aim of this study is to provide comparative data on the safety, efficacy, and recovery profiles of both anesthesia methods in the context of pediatric surgical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3-12 years
- •Patients weighing over 10 kilograms
- •Patients who will undergo inguinal hernia surgery
- •ASA (American Society of Anesthesiologists) classification I and II pediatric patients.
排除标准
- •Absence of systemic illness.
- •ASA (American Society of Anesthesiologists) classification III pediatric patients.
研究组 & 干预措施
TOTAL INTRAVENOUS ANESTHESIA GROUP
After premedication, anesthesia induction will be performed as per routine. Upon reaching the target Bispectral Index (BIS) level (40-60) and ensuring muscle relaxation, the airway will be secured with an appropriately sized endotracheal tube or laryngeal mask airway (LMA). The target concentration of Propofol in the effect site will be set at 3 mcg/ml using a Target-Controlled Infusion (TCI) device. Controlled ventilation will be conducted with 50% oxygen/air mixture, adjusting mechanical ventilation parameters to maintain End-Tidal Carbon Dioxide (EtCO2) levels between 35-45 mmHg.
干预措施: Target Controlled İnfusion (Device)
The Patient Group Receiving Inhalation Anesthesia
Patients will be induced with the same anesthesia as Group I, and BIS values will be adjusted to be between 40-60 at the routinely used inhalation gas level of sevoflurane. Patients will be given controlled ventilation with 50% Oxygen/air, and mechanical ventilation materials will be adjusted so that the end tidal carbon dioxide level (EtCO2) will be 35-45 mmHg.
干预措施: Inhalation anesthetic (Drug)
结局指标
主要结局
Modified Aldrete Scoring System
时间窗: after surgery 1 hours
The effects on recovery were monitored within the first hour of the postoperative period using the Modified Aldrete Scoring System (MASS). Totally 0-10 points can be given by MASS. Higher scores predicts better recovery.
次要结局
- blood pressure (mmHg)(after surgery 1 hours)
- heart rate (Beats/minute)(after surgery 1 hours)
研究者
Özlem ÖZ GERGİN
Associate Professor
TC Erciyes University