Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Effects of Sedation and Analgesia on the Surgical Pleth Index (SPI)|
- Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints [ Time Frame: 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Patients undergoing short-term surgery (30-90 min) under general anesthesia
Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
Spinal + Sedation
Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
- 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.
- 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.
- In consistence with previously published data no changes of SPI should occur due to standardized sedation with propofol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789438
|Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel|
|Kiel, Germany, 24105|
|Study Director:||Berthold Bein, PD Dr med||Institut für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel|