Conox-Guided Anesthesia in Pediatric Adenotonsillectomy
A Randomized Controlled Trial Evaluating the Effect of qCON/qNOX-Guided Anesthesia on Clinical Outcomes in Pediatric Adenotonsillectomy
This study aims to evaluate the effect of Conox (qCON/qNOX)-guided anesthesia on intraoperative anesthetic drug consumption and postoperative outcomes in pediatric patients undergoing adenotonsillectomy. Conox is a non-invasive EEG-based monitoring system that provides indices of both hypnosis and nociception.
In this randomized controlled trial, children aged 3-12 years will be assigned to either a Conox-guided anesthesia group or a standard monitoring group. The primary outcome of the study is total intraoperative opioid consumption, assessed from anesthesia induction to the end of surgery. Secondary outcomes include emergence time, extubation time, postoperative agitation, pain scores, and correlation between qCON/qNOX values and hemodynamic parameters.
研究概览
详细说明
This randomized controlled trial is designed to investigate the impact of Conox (qCON/qNOX)-guided anesthesia on anesthetic management and clinical outcomes in pediatric patients undergoing adenotonsillectomy. Conox is a non-invasive EEG-based monitoring device that simultaneously provides indices of hypnotic depth (qCON) and nociception (qNOX), allowing for more precise anesthetic titration.
A total of 128 children aged 3-12 years with ASA physical status I-II scheduled for elective adenotonsillectomy will be enrolled. Participants will be randomized into two groups using a sealed envelope method. In the Conox group, anesthetic depth and analgesic administration will be guided by qCON and qNOX values in addition to standard monitoring. In the control group, anesthesia will be managed using conventional clinical parameters such as heart rate and mean arterial pressure.
All patients will receive a standardized anesthesia protocol including propofol, fentanyl, rocuronium for induction, and sevoflurane for maintenance. The primary outcome of the study is total intraoperative opioid consumption, assessed from anesthesia induction to the end of surgery. Secondary outcomes include emergence time, extubation time, postoperative agitation, pain scores, and correlation between qCON/qNOX values and hemodynamic variables.
The study aims to determine whether Conox-guided anesthesia can optimize anesthetic drug use, improve postoperative recovery, and enhance patient safety in pediatric anesthesia practice.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Kayseri、土耳其(türkiye)
- 招聘中
- Kayseri Şehir Hastanesi
-
接触:
- ÇİĞDEM ÜNAL KANTEKİN
- 电话号码:+903523157700 +905054433056
- 邮箱:drcgdm@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
Children aged 3 to 12 years ASA physical status I-II Scheduled for elective adenotonsillectomy No acute infection or systemic disease Parent or legal guardian able to provide written informed consent
Exclusion Criteria:
Skin lesions or anatomical abnormalities preventing placement of EEG electrodes History of neurological disease, including epilepsy or neurological syndromes Body mass index above the 95th percentile for age Previous pharyngeal surgery History of anesthesia-related complications Absence of written informed consent from a parent or legal guardian
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Conox Group
Patients will receive anesthesia management guided by qCON and qNOX values obtained from the Conox monitor in addition to standard monitoring.
|
EEG-based monitoring device providing qCON and qNOX indices to guide anesthetic depth and analgesia.
|
|
有源比较器:Standard Monitoring Group
Patients will receive anesthesia management based on standard clinical parameters such as heart rate and mean arterial pressure without Conox guidance.
|
Anesthesia management based on conventional clinical parameters such as heart rate and blood pressure.
|
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 |
|---|---|---|
|
Total Intraoperative Opioid Consumption
大体时间:Intraoperative period
|
Total cumulative opioid dose administered from induction of anesthesia until the end of surgery.
|
Intraoperative period
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.