Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Intraoperative opioid use
研究概览
简要总结
This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •ASA score I-III
- •surgery for gastric or hepatobiliary or pancreatic neoplasia
排除标准
- •pregnancy
- •lactation
- •neuraxial or regional anesthesia
- •chronic treatment with drugs that can influence autonomic nervous system
- •diuretics or nitroglycerin administration on the day of surgery
- •severe neurological disability
- •severe hemodynamic instability
- •chronic pain
- •chronic opioid treatment
- •allergy to any of the study drugs
- •severe untreated disease or organ failure
- •pacemaker
- •emergency surgery
- •patient refusal to participate
研究组 & 干预措施
+ NOL + lidocaine group
NOL guided analgesia and intravenous lidocaine infusion
干预措施: NOL (Device)
+ NOL - lidocaine group
NOL guided analgesia without intravenous lidocaine infusion
干预措施: NOL (Device)
+ NOL + lidocaine group
NOL guided analgesia and intravenous lidocaine infusion
干预措施: Lidocaine Intravenous Infusion (Drug)
- NOL + lidocaine group
group without NOL monitoring but with lidocaine intravenous infusion
干预措施: Lidocaine Intravenous Infusion (Drug)
结局指标
主要结局
Intraoperative opioid use
时间窗: intraoperative
We aim to examine the effect nociception level index monitoring in major abdominal surgery on intraoperative nociception management by measuring total opioid use in NOL monitored patients vs standard care according to the anesthesiologists judgement. Moreover, crossreference interventional arms will examine the effect of intraoperative administration of lidocaine in NOL and no NOL groups on intraoperative opioid use. Intraoperative opioid use will be time adjusted ( depending on the duration of surgery) and weight adjusted (depending on the weight of the patient)- mg of opioid/hour/kg
次要结局
- Intraoperative pulse(intraoperative)
- Intraoperative blood pressure(intraoperative)
- Postoperative pain scores(24 hours)
- Postoperative opioid use(24 hours)
- Lidocaine related adverse events(24 hours)
- Opioid related adverse events(24 hours)
研究者
Osoian Cristiana
Principal Investigator
Iuliu Hatieganu University of Medicine and Pharmacy