Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia|
- Sufentanil consumption [ Time Frame: during induction and end of anesthesia (1-3 hours) ] [ Designated as safety issue: No ]We will measure the sufentanil consumption during beginning of anesthesia and extubation in microgram per hour.
- hemodynamic stability [ Time Frame: from beginning of anesthesia until discharge to ward (1day) ] [ Designated as safety issue: No ]Hemodynamic stability is measured as number of the following events during anesthesia: hypotension, hypertension, tachykardia, bradykardia.
|Study Start Date:||March 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: SPI guided arm
sufentanil was adjusted to SPI level
Drug: administration of sufentanil
10 microgram sufentanil were given when SPI above 50 for more then 20 sec
Active Comparator: Standard practise
Sufentanil was given at standard practise
sufentanil was given at standard practise
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525537
|University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.|
|Kiel, Germany, 24105|
|Study Chair:||Berthold Bein, MD, PhD||University of Schleswig-Holstein|
|Principal Investigator:||Matthias Gruenewald, MD||University of Schleswig-Holstein|