Evaluation Of The Analgesia Nociception Index vs. Surgical Pleth Index Under General And Regional Anaesthesia And The Effect Of Posture. A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ANI vs. SPI
研究概览
简要总结
There is a lack of sufficient analgesia monitoring apart from surrogate parameters. The analgesia nociception index (ANI) shall be evaluated under general and regional anaesthesia.
详细描述
While sophisticated haemodynamic monitoring as well as depth of neuromuscular block and sedation are established in daily clinical routine monitoring of analgesia remains poorly represented. The surgical pleth index (SPI) algorithm takes into account both central and peripheral sympathetic tone via the normalised heart beat interval and the plethysmographic pulse wave amplitude and has been described before. A more detailed investigation on the SPI and its behaviour under a posture maneuver shows the limitation of the device.
Another device developed calculates the "analgesia nociception index" (ANI) by heart rate variability and was launched into the market in 2010. However, the effect of posture - to our knowledge - has not yet been studied. The change of body positioning during surgery is regularly necessary in order to improve surgical access to anatomic structures. These alterations in positioning are known to be accompanied by changes in haemodynamic parameters.
The aim of this study was to evaluate the ANI in patients undergoing elective surgery in lithotomy position.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •≥ 18 years
- •Body mass index (BMI) < 35 kg m2
- •American Society of Anesthesiologists (ASA) status I-III
- •Elective urology and gynaecology surgery in lithotomy position
- •15 healthy volunteers were included in the study as a control group
排除标准
- •Age < 18 years
- •ASA status IV or higher
- •BMI ≥ 35 kg m2
- •Chronic heart rhythm disorders
- •Implanted pacemakers
- •Patients with a history of chronic pain and emergency surgery
结局指标
主要结局
ANI vs. SPI
时间窗: Data will be assessed and collected immediately after completion of each case of surgery.
Evaluation of the ANI and comparison to SPI (same unit of measure, both ranging between 0-100, no dimension) in patients undergoing elective surgery in lithotomy position. Evaluation and change of ANI and SPI values at pre-defined timepoints: 1) Baseline, 2) before induction of anaesthesia, during 3) intubation or spinal punction, 4) posture maneuver, 5) skin incision 6) surgical suture, 7) post anesthetic care unit stay (arrival).
次要结局
未报告次要终点
研究者
Timo Iden
Dr. med.
University Hospital Schleswig-Holstein