Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Sufentanil consumption
研究概览
简要总结
The aim of the present study was to compare SPI guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular stability, less use of analgetics and shorter recovery from anesthesia.
详细描述
General anesthesia can be considered as a combination of hypnosis, antinociception, and immobility. The monitoring of hypnosis and immobility has been established in clinical practise, however for the evaluation of antinociception a valid monitoring is missing.
The Surgical Pleth Index (SPI; former named Surgical Stress Index-SSI) is a multivariate index derived non invasively from finger plethysmographic signal. It has been demonstrated to correlate with surgical stress intensity. In the setting of total intravenous anesthesia TIVA our group could show beneficial effects of SPI guided analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted events.
Therefore, we wanted examine whether these beneficial effects of SPI guided anesthesia can be transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and the opioid sufentanil.
The following hypotheses have been made:
- SPI guided analgesia will result in less sufentanil consumption
- SPI guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia, and less opioid use in post operative period
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 - 65 years
- •ASA physical status I or II
- •elective surgery under general anesthesia of 1-2 hours
- •written informed consent
排除标准
- •pregnancy
- •history of cardiac arrhythmia
- •presence of any neuromuscular opr neurologic disease
- •use of CNS active medication or alcohol/illicit drug abuse -
研究组 & 干预措施
SPI guided arm
sufentanil was adjusted to SPI level
干预措施: administration of sufentanil (Drug)
Standard practise
Sufentanil was given at standard practise
干预措施: sufentanil (Drug)
结局指标
主要结局
Sufentanil consumption
时间窗: during induction and end of anesthesia (1-3 hours)
We will measure the sufentanil consumption during beginning of anesthesia and extubation in microgram per hour.
次要结局
- hemodynamic stability(from beginning of anesthesia until discharge to ward (1day))
研究者
Berthold Bein
Prof. Dr. med.
University Hospital Schleswig-Holstein