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临床试验/NCT07766629
NCT07766629尚未招募不适用

Age-Stratified Recovery Trajectories Following Propofol-Based Total Intravenous Anesthesia: A Comparative Study Between Toddlers (3-6 Years) and Older Children (6-12 Years)

Assiut University0 个研究点目标入组 64 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
主要终点
Time to Achieve Fast-Track Phase II Recovery Readiness

研究概览

简要总结

This observational study aims to compare how quickly and smoothly younger children (ages 3 to 6 years) recover from general anesthesia compared to older children (ages 6 to 12 years).

While inhalational anesthesia (breathing in anesthetic gases) has traditionally been the standard for pediatric surgeries, total intravenous anesthesia (TIVA) using a short-acting medication called propofol is increasingly being used. Propofol TIVA offers several benefits, including reduced postoperative nausea and vomiting, less airway irritation, a smoother waking process, and an earlier readiness to go home. However, because children's bodies and metabolisms change rapidly as they grow, the way propofol is processed by and clears from the body varies significantly by age.

Currently, there is limited evidence detailing exactly how these age-related differences affect recovery times. To investigate this, researchers will monitor 64 children undergoing elective surgeries (lasting between 30 and 120 minutes) who receive propofol TIVA as their primary anesthetic.

After the procedure, the study will measure the exact time it takes for participants in both age groups to meet specific, standardized safe-discharge criteria (known as Phase II recovery readiness). Researchers will also track several other important recovery factors, including the time it takes for children to open their eyes, pain levels, the occurrence of emergence delirium (agitation or confusion upon waking), and any breathing-related complications. By comparing the recovery trajectories of toddlers and older children, this research seeks to improve postoperative care planning and provide clearer expectations for pediatric intravenous anesthesia.

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

  • •Age 3-12 years
  • •Elective surgery under general anaesthesia
  • •Surgical duration 30-120 minutes
  • •Propofol TIVA as the primary anesthetic technique

排除标准

  • •Neurological disorders
  • •Developmental delay
  • •Hepatic or renal impairment
  • •Obesity (>95th percentile)
  • •Concomitant sedative medications

研究组 & 干预措施

Toddlers (3-6 years)

Pediatric patients aged 3 to 6 years undergoing elective surgery under general anesthesia. This cohort receives a standardized propofol-based total intravenous anesthesia (TIVA) protocol, which includes induction with propofol (2-3 mg/kg IV) and maintenance via continuous infusion utilizing Kataria model predictions.

Older Children (6-12 years)

Pediatric patients aged 6 to 12 years undergoing elective surgery under general anesthesia. This cohort receives a standardized propofol-based total intravenous anesthesia (TIVA) protocol, which includes induction with propofol (2-3 mg/kg IV) and maintenance via continuous infusion utilizing Kataria model predictions.

结局指标

主要结局

Time to Achieve Fast-Track Phase II Recovery Readiness

时间窗: 2 hours post-surgery

The time elapsed in minutes from the end of surgery (defined as the placement of the last stitch) until the patient achieves Phase II recovery readiness. Readiness is determined using the White Fast-Track Score, which requires patients to achieve a total score of 12 or greater with no individual component scoring less than 1.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Ashraf Salah Ali

Resident of Anesthesia

Assiut University

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