Monitoring Nociception Using NoL Index and Its Implications in Reducing Opioid-Related Complications in Laparoscopic Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 282
- 主要终点
- Reduction in Postoperative Opioid-Related Complications
研究概览
简要总结
This study aims to determine if optimal intraoperative nociception monitoring using the NoL index can reduce postoperative complications related to opioid use in laparoscopic abdominal surgery. The hypothesis is that guided nociception monitoring decreases opioid-related complications and improves postoperative outcomes.
详细描述
The study is a prospective, observational cohort study conducted across multiple centers. It aims to evaluate the impact of intraoperative nociception monitoring on postoperative opioid-related complications. The study will involve two groups of patients undergoing laparoscopic abdominal surgery: one group with visible NoL monitoring and another with non-visible NoL monitoring.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Scheduled for laparoscopic abdominal surgery
- •Undergoing balanced general anesthesia
- •ASA physical status I-III
- •Signed informed consent
排除标准
- •Refusal to participate
- •Communication barriers
- •Multimodal, opioid-free, or regional epidural anesthesia
- •ASA IV or V
- •Pregnant or breastfeeding women
- •Open or emergency abdominal surgery
- •Post-surgery transfer to ICU or Recovery Unit
结局指标
主要结局
Reduction in Postoperative Opioid-Related Complications
时间窗: From the end of surgery up to 48 hours postoperatively
The primary outcome measure will evaluate the incidence of postoperative opioid-related complications in patients undergoing laparoscopic abdominal surgery. Complications include nausea, vomiting, respiratory depression, and opioid-induced hyperalgesia. The study aims to determine if the use of the NoL monitor to guide intraoperative analgesia reduces these complications compared to standard hemodynamic monitoring.
次要结局
- Postoperative Pain Scores(At 1, 6, 12, 24, and 48 hours postoperatively)
- Length of Hospital Stay(From admission to discharge, up to 7 days postoperatively)
- Intraoperative Opioid Consumption(During the surgical procedure)