Observational Study Evaluating the Impact of Surgical Stress Suppression During Opioid Free Anesthesia on Postoperative Inflammation During Major Surgery.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CRP 24 hours postoperative
研究概览
简要总结
Patients undergoing surgery under opioid free general anesthesia (OFA) are monitored with antinociceptive devices like NOL or ANI that measures sympathetic activity but are invisible for the attending anesthesiologist . Observational study comparing patients with sufficient suppression of sympathetic reactions with patients having insufficient suppression on hemodynamic stability, post operative sedation, pain and inflammatory markers.
详细描述
all patients get an opioid free anesthesia using dexmedetomidine, lidocaine, ketamine and magnesium. dosing is according to the attending anesthesiologist.
total dose of each drug and duration of anesthesia are recorded. Antinociceptive devices measures how long the patient is during anesthesia having a nociceptive level nociception level index (NOL) or Analgesia Nociception Index (ANI) above normal without showing the data to the attending anesthesiologist.
Relationship is calculated between on one side the hemodynamic stability, postoperative sedation, pain, postoperative CRP and on the other side the time NOL is above 20 or ANI is below 50.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •major surgical procedures without need for regional anesthesia
排除标准
- •allergy to one of the anesthetics used
- •major liver, renal cardiac or pulmonary disease reducing normal function
结局指标
主要结局
CRP 24 hours postoperative
时间窗: 24 hours postoperative
measure chronic reactive protein (CRP) biomarker of surgical inflammation
次要结局
- hemodynamic stability(intraoperative)
- postoperative pain using VAS score(up to 4 hours postoperative during post anesthetic care unit (PACU) stay)
- postoperative sedation using Ramsay score(first 4 hours postoperative during PACU stay)
- postoperative opioids used(first 24 hours postoperative)
研究者
Jan Mulier
Principal investigator
AZ Sint-Jan AV