跳至主要内容
临床试验/NCT07445659
NCT07445659招募中不适用

The Effect of qCON/qNOX-Guided Anesthesia Using the Conox Monitor on Clinical Outcomes in Patients Undergoing Thyroidectomy Surgery

Kayseri City Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年4月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Total intraoperative opioid consumption

研究概览

简要总结

The aim of this study is to evaluate the effect of using the non-invasive Conox monitor on intraoperative opioid consumption. Additionally, the study aims to assess the impact of Conox monitoring on recovery time, postoperative agitation rate, and pain scores, and to investigate the correlation between qCON and qNOX values and conventional hemodynamic parameters.

详细描述

In recent years, both nationally and internationally, strategies aimed at minimizing perioperative opioid use and protocols designed to enhance postoperative recovery have gained increasing importance in anesthesia practice. The primary objectives of these developments are to improve patient care, minimize undesirable events, promote earlier discharge, and prevent long-term adverse outcomes .

Although opioids play an essential role in multimodal perioperative analgesia due to their proven efficacy, safety, and titratability, it is important to use the lowest effective opioid dose possible.

In thyroid surgery, neuromuscular blocking agents are not used after induction. Maintenance of anesthesia is achieved with inhalational anesthetic agents and opioids. Therefore, adequate titration of anesthetic depth directly affects postoperative comfort, drug consumption, and overall recovery .

The Conox monitor is a non-invasive, EEG-based monitoring device that simultaneously provides hypnosis (qCON) and analgesia/nociception (qNOX) indices. The current anesthesia depth monitoring devices used in our anesthesia unit allow monitoring of anesthetic depth only. However, nociception is one of the critical components of anesthesia. Nociception is defined as the patient's ability to respond to painful stimuli in relation to the effectiveness of administered analgesic agents. Proper management of painful stimuli during surgery enhances patient safety and allows optimal drug dosing.

By reducing unnecessary drug administration, postoperative complications may decrease and recovery can be positively influenced. The Conox monitoring system, based on EEG signals, offers the opportunity to monitor both anesthetic depth and nociception simultaneously . Combined monitoring of anesthetic depth and nociception provides anesthesiologists with a safer, more sensitive, and comprehensive monitoring approach, thereby improving the quality of patient care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-70 years
  • Thyroidectomy cases with ASA physical status I-II
  • Patients who have provided written informed consent

排除标准

  • Skin lesions preventing EEG electrode placement
  • Neurological disorders (e.g., epilepsy)
  • Anticipated difficult airway

研究组 & 干预措施

control

Active Comparator

Induction: Propofol 2-3 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg. Maintenance: Sevoflurane (1.0-1.3 MAC) and remifentanil infusion at 0.1 µg/kg/h.In the control group, conventional titration will be guided by heart rate and mean arterial pressure changes.

Total intraoperative opioid consumption, recovery time, extubation time, agitation scores, and pain scores will be recorded.

干预措施: standard anesthesia management (Other)

Conox

Experimental

Induction: Propofol 2-3 mg/kg, fentanyl 2 µg/kg, and rocuronium 0.6 mg/kg. Maintenance: Sevoflurane (1.0-1.3 MAC) and remifentanil infusion at 0.1 µg/kg/h.

In the Conox group, anesthetic and analgesic titration will be performed targeting qCON values of 40-60 and qNOX values of 30-60.

干预措施: Connox EEG Monitoring (Device)

结局指标

主要结局

Total intraoperative opioid consumption

时间窗: Intraoperative period

Total intraoperative opioid consumption will be defined as the cumulative dose of remifentanil (µg/kg) administered from induction of anesthesia until completion of surgery (skin closure). Data will be obtained from anesthesia records and analyzed comparatively between the study groups.

次要结局

  • Correlation between qCON/qNOX values and hemodynamic parameters(Intraoperative period)
  • Postoperative pain scores(Within the first 30 minutes after surgery in the PACU (assessed every 5 minutes))

研究者

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Çiğdem Ünal Kantekin

Associate Professor of Anesthesiology

Kayseri City Hospital

研究点 (1)

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