ANI and SPI Guided Intraoperative Analgesia in Patients Undergoing Neurosurgical Procedures Under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Cortisol serum level
研究概览
简要总结
There is accumulating evidence that inappropriate analgesia is asssociated with increasing risk of perioperative complications. The aim of the study is to compare intraoperative analgesia guided according to different methods of intraoperative analgesia monitoring, ANI and SPI respectively.
详细描述
The Surgical Pleth Index (SPI) and ANI (Analgesia Nociception Index) has been developed for monitoring of adequacy of analgesia during surgery.
The investigators want to compare anesthesiologist guided intraoperative analgesia with intraoperative analgesia guieded by ANI or SPI.
The following hypotheses have been made:
- Anesthesiologist guided analgesia will result in lower surgical stress
- Anesthesiologist guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing scheduled neurosurgical procedures under general anesthesia
- •ASA physical status I - III
- •elective procedures with estimated duration 1 - 3 hours
排除标准
- •Presence of non-sinus rhythm
- •pacemaker
- •planned postoperative ventilation
- •procedures with planned awake intervals
- •chronic pain with opioid medication
- •opioid addiction
- •epidural administration of local anaesthetic in combination with opioid
- •corticosteroid use
- •hormonal contraception
- •chronic respiratory disease with known respiratory failure
研究组 & 干预措施
Anesthesiologist quided analgesia
Sufentanil anesthesiologist analgesia is based on anesthesiologist decision.
干预措施: Sufentanil anesthesiologist analgesia (Drug)
ANI guided analgesia
Sufentanil ANI analgesia based on ANI analgesia monitor figures.
干预措施: Sufentanil ANI analgesia (Drug)
SPI guided analgesia
Sufentanil SPI analgesia is based on the SPI analgesia monitor figures.
干预措施: Sufentanil SPI analgesia (Drug)
结局指标
主要结局
Cortisol serum level
时间窗: End of surgery
nmol/l
次要结局
- Time to spontaneous ventilation(From the end of anesthesia up to two hours)
- Time to extubation(From the end of anesthesia up to two hours)
- Mean pain intensity at the ICU/recovery room(From the admission to the ICU or recovery room up to 2 hours postoperatively)
- Number of doses of opioid analgesics(Until the end of the 3rd postoperative day)
- Postoperative respiratory complications(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Sufentanil dose(From the beginning of anesthesia up to the end of anesthesia, an expacted average duration of 2 hours)
- Pain intensity at recovery room admission(At the time of ICU/recovery room admission, up to 15 minutes after ICU/recovery admission)
- Time to achievement of normal end-tidal CO2 value(From the end of anesthesia up to two hours)
- Pain intensity at the time of departure from the operating theater(At the time of departure from the operating room, up to 30 min from the end of anesthesia)
- Pain intensity(3rd postoperative day)
- Number of doses of non-opioid analgesics(Until the end of the 3rd postoperative day)
- Length of postoperative hospital stay(From the day of surgery up to the end of hospital stay, an expected average of 2 weeks)
研究者
Dostalova Vlasta, MD, PhD
Dr.
University Hospital Hradec Kralove