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Minimal- Versus High-Flow Sevoflurane and Emergence Agitation in Pediatric Surgery

2026年6月3日 更新者:Hülya Kaşıkara、Ankara City Hospital Bilkent

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

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.

研究概览

地位

主动,不招人

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • - 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:opioid-free minimal-flow anesthesia
In this arm, pediatric patients undergoing infraumbilical surgery under opioid-free general anesthesia receive a caudal epidural block after tracheal intubation. Anesthesia is then maintained with minimal-flow sevoflurane.
In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.
实验性的:Opioid-Free High-Flow anesthesia
Patients receive opioid-free high-flow sevoflurane anesthesia during maintenance of general anesthesia combined with caudal block.
In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Emergence agitation assessed by Pediatric Anesthesia Emergence Delirium scale
大体时间:First 30 minutes in PACU
Pediatric Anesthesia Emergence Delirium (PAED) Scale score ranging from 0 to 20 points. Higher scores indicate more severe emergence delirium. Emergence delirium will be defined as a PAED score ≥10.
First 30 minutes in PACU

次要结果测量

结果测量
措施说明
大体时间
Emergence agitation assessed by Watcha scale
大体时间:First 30 minutes in the post-anesthesia care unit (PACU)
Emergence agitation will be assessed using the Watcha scale (1-4 points), with higher scores indicating more severe agitation. Patients with a Watcha score ≥3 will be classified as having emergence agitation.
First 30 minutes in the post-anesthesia care unit (PACU)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月22日

初级完成 (估计的)

2026年6月22日

研究完成 (估计的)

2026年6月30日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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