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临床试验/NCT07635004
NCT07635004进行中(未招募)不适用

Comparison of the Effects of Minimal-Flow and High-Flow Sevoflurane on Emergence Agitation in Opioid-Free Pediatric Surgeries During General Anesthesia Maintenance

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年4月22日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1

研究概览

简要总结

This study aims to evaluate the effects of minimal-flow sevoflurane compared with high-flow sevoflurane during maintenance of general anesthesia on postoperative emergence agitation in opioid-free pediatric infraumbilical surgeries. Patients will be randomly assigned to receive either opioid-free minimal-flow anesthesia combined with caudal block or opioid-free high-flow anesthesia combined with caudal block.

The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale and the Watcha scale. Secondary outcomes include the incidence of postoperative nausea and vomiting and recovery characteristics. In addition, all patients will be followed up via telephone at 3 months postoperatively to assess the presence of persistent chronic or neuropathic pain at the surgical site.

The findings of this study may contribute to optimizing anesthesia strategies and improving postoperative outcomes in pediatric patients.

详细描述

Emergence agitation (EA) is a common and clinically significant complication in pediatric patients following general anesthesia, particularly after the use of volatile anesthetic agents such as sevoflurane. The etiology of EA is multifactorial and may be associated with rapid emergence, postoperative pain, preoperative anxiety, and the use of opioids. Strategies aimed at reducing opioid consumption and optimizing anesthetic techniques may help improve postoperative recovery profiles in children.

Opioid-free anesthesia (OFA) has gained increasing attention as a multimodal approach that minimizes or eliminates intraoperative opioid use while maintaining adequate analgesia and hemodynamic stability. In addition, low-flow anesthesia techniques may contribute to improved respiratory conditions, better humidification, and more stable anesthetic depth, which could potentially influence emergence characteristics. However, the combined effect of opioid-free and low-flow anesthesia on emergence agitation in pediatric populations has not been sufficiently investigated.

In this prospective, randomized, single-blind study, pediatric patients undergoing infraumbilical surgery will be allocated to receive either opioid-free minimal-flow anesthesia combined with caudal epidural block or conventional anesthesia management. Emergence agitation will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale as the primary outcome, and the Watcha scale as a secondary assessment tool. Additional outcomes include postoperative pain scores, incidence of postoperative nausea and vomiting (PONV), and recovery parameters. This study aims to provide evidence on whether opioid-free minimal-flow anesthesia can improve postoperative behavioral outcomes and enhance recovery quality in pediatric patients.

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)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients aged 2-10 years
  • ASA physical status I-II
  • Scheduled for elective infraumbilical surgery
  • Planned to receive general anesthesia with caudal block
  • Written informed consent obtained from parents or legal guardians

排除标准

  • - Refusal of parental consent
  • Known allergy to study drugs
  • Neurological or developmental disorders
  • Psychiatric disorders or use of psychoactive medications
  • Chronic pain or regular analgesic use
  • Contraindication to caudal block (infection at site, coagulopathy, anatomical abnormality)
  • Significant cardiovascular, respiratory, hepatic, or renal disease
  • Emergency surgery
  • Signs of failed caudal epidural block, defined as a greater than 20% increase in heart rate or blood pressure in response to surgical stimulation, an increase in bispectral index (BIS) values, or the requirement for additional intravenous anesthetic agents.

研究者

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

Hülya Kaşıkara

Assoc.Prof.MD

Ankara City Hospital Bilkent

研究点 (1)

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