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临床试验/NCT00789438
NCT00789438
已完成
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The Effects of Sedation and Analgesia on the Surgical Pleth Index (SPI)

University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 69 人2008年10月
适应症StressPain

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Stress
发起方
University Hospital Schleswig-Holstein
入组人数
69
试验地点
1
主要终点
Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints
状态
已完成
最后更新
15年前

概览

简要总结

The Surgical Pleth index (SPI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.

详细描述

1. Spinal anaesthesia secures full pain relieve and muscle relaxation usually in the lower part of the body. Thus, SPI - a measure that reflects pain during surgery - may not exceed significantly compared to baseline. It may slightly increase only during administration of the block. 2. Increasing SPI values due to surgery under subarachnoid block may reflect intraoperative patient's stress mediated by activation of the autonomic nervous system, specifically sympathetic activation. 3. In consistence with previously published data no changes of SPI should occur due to standardized sedation with propofol.

注册库
clinicaltrials.gov
开始日期
2008年10月
结束日期
2010年5月
最后更新
15年前
研究类型
Observational
性别
All

研究者

发起方
University Hospital Schleswig-Holstein

入排标准

入选标准

  • surgical procedures feasible under general or spinal anesthesia
  • duration between 30 and 90 min
  • ASA status I,II or III

排除标准

  • contraindications against one of the anesthesia methods
  • age under 18
  • emergencies
  • chronical pain history
  • lack of sinus rhythm

结局指标

主要结局

Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints

时间窗: Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay

Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.

研究点 (1)

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